Healthcare Sales & Marketing Network News: PDUFA

Searching News Database: PDUFA

HSMN NewsFeed - 29 Dec 2025
FDA Accepts for Review INOVIO's BLA for INO-3107 for the Treatment of Adults with Recurrent Respiratory Papillomatosis (RRP)
Biopharmaceuticals FDA

HSMN NewsFeed - 28 Nov 2025
Vanda Pharmaceuticals Provides Regulatory Update on Tradipitant for Motion Sickness
Biopharmaceuticals FDA

HSMN NewsFeed - 10 Apr 2025
BrainStorm Cell Therapeutics Submits IND Amendment to FDA, Paving the Way for Phase 3b Trial of NurOwn(R) in ALS
Regenerative Medicine Neurology FDA

HSMN NewsFeed - 5 Mar 2025
Jazz Pharmaceuticals to Acquire Chimerix, Further Diversifying Oncology Portfolio
Biopharmaceuticals Oncology Mergers & Acquisitions

HSMN NewsFeed - 29 Jul 2024
Syndax Announces PDUFA Action Date Extension for Revumenib NDA for Relapsed or Refractory KMT2Ar Acute Leukemia
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 26 Jun 2024
BrainStorm Cell Therapeutics Reaches Alignment with FDA on CMC Aspects of Phase 3b NurOwn(R) Clinical Trial
Regenerative Medicine Neurology FDA

HSMN NewsFeed - 25 Jun 2024
Halozyme Announces Roche's OCREVUS(R) SC with ENHANZE(R) Receives European Commission Approval for Relapsing and Primary Progressive Multiple Sclerosis
Biopharmaceuticals Neurology Regulatory

HSMN NewsFeed - 23 Feb 2024
BrainStorm Cell Therapeutics Submits Special Protocol Assessment (SPA) Request to FDA for Phase 3b Trial of NurOwn(R) in ALS
Regenerative Medicine Neurology FDA

HSMN NewsFeed - 18 Aug 2023
FDA grants priority review for full approval of TARPEYO for the treatment of IgA Nephropathy
Biopharmaceuticals FDA

HSMN NewsFeed - 12 Jul 2023
BrainStorm Cell Therapeutics Appoints Bob Dagher, M.D., as Executive Vice President and Chief Development Officer
Regenerative Medicine Personnel

HSMN NewsFeed - 28 Sep 2022
Harrow Announces U.S. FDA Approval of IHEEZO(TM) (Chloroprocaine Hydrochloride Ophthalmic Gel) 3% for Ocular Surface Anesthesia
Biopharmaceuticals Ophthalmology FDA

HSMN NewsFeed - 18 Aug 2022
U.S. FDA Accepts Astellas' New Drug Application for Fezolinetant
Biopharmaceuticals FDA

HSMN NewsFeed - 27 Aug 2021
European Commission Approves BioMarin's VOXZOGO(R) (vosoritide) for the Treatment of Children with Achondroplasia from Age 2 Until Growth Plates Close
Biopharmaceuticals Regulatory

HSMN NewsFeed - 25 Jun 2021
Jazz Pharmaceuticals Announces Orphan Drug Exclusivity for Xywav(TM) (calcium, magnesium, potassium, and sodium oxybates) Oral Solution
Biopharmaceuticals FDA

HSMN NewsFeed - 25 Jun 2021
BioMarin Receives Positive CHMP Opinion in Europe for Vosoritide for the Treatment of Children with Achondroplasia from Age 2 Until Growth Plates Close
Biopharmaceuticals Regulatory

HSMN NewsFeed - 30 Dec 2020
Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce Final Results of BRIDGE Phase III Open-Label, Switch-Over Clinical Trial Evaluating Pegunigalsidase Alfa for the Treatment of Fabry Disease
Biopharmaceuticals

HSMN NewsFeed - 27 Nov 2020
Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce Extension of PDUFA Date for Pegunigalsidase Alfa for the Proposed Treatment of Fabry Disease
Biopharmaceuticals FDA

HSMN NewsFeed - 10 Aug 2020
Mallinckrodt Announces U.S. FDA Filing Acceptance of Biologics License Application for StrataGraft(R) Regenerative Skin Tissue for Treatment of Adults with Deep Partial-thickness Thermal Burns
Biopharmaceuticals Regenerative Medicine FDA

HSMN NewsFeed - 3 Aug 2020
FDA Accepts and Grants Priority Review of Vanda's Applications for HETLIOZ(R) (tasimelteon) in the Treatment of Smith-Magenis Syndrome
Biopharmaceuticals FDA

HSMN NewsFeed - 13 May 2020
Arbor Pharmaceuticals Announces FDA Filing Acceptance of New Drug Application (NDA) for AR19, an Investigational ADHD Prescription Stimulant Treatment Specifically Designed to Resist Physical Manipulation for Nonmedical Misuse or Abuse
Biopharmaceuticals FDA

HSMN NewsFeed - 16 Apr 2020
Provention Bio Initiates Rolling Submission of Biologic License Application for Teplizumab for the Delay or Prevention of Clinical Type 1 Diabetes in At-Risk Individuals
Biopharmaceuticals FDA

HSMN NewsFeed - 13 Apr 2020
ANI Announces FDA Acceptance of Supplemental Filing for Cortrophin(R) Gel 80 U/mL
Biopharmaceuticals FDA

HSMN NewsFeed - 1 Apr 2020
Blueprint Medicines Announces the Achievement of Key Portfolio Milestones
Biopharmaceuticals Oncology

HSMN NewsFeed - 24 Feb 2020
Lipocine Announces Regulatory Path Forward for TLANDO(TM) Resubmission
Biopharmaceuticals FDA

HSMN NewsFeed - 17 Feb 2020
PharmaMar and Jazz Pharmaceuticals Announce FDA Acceptance and Priority Review of New Drug Application for Lurbinectedin in Relapsed Small Cell Lung Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 10 Feb 2020
Biohaven's Troriluzole Study For Generalized Anxiety Disorder (GAD) Misses Primary Endpoint
Biopharmaceuticals

HSMN NewsFeed - 29 Jan 2020
Lilly Receives FDA Priority Review for the Selpercatinib New Drug Application
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 11 Dec 2019
Correvio Announces Intention to Explore Strategic Alternatives to Maximize Stakeholder Value
Biopharmaceuticals Cardiology FDA

HSMN NewsFeed - 26 Nov 2019
Evofem Biosciences Resubmits New Drug Application to U.S. FDA for Amphora(R) for the Prevention of Pregnancy
Biopharmaceuticals FDA

HSMN NewsFeed - 16 Sep 2019
Seattle Genetics and Astellas Announce U.S. FDA Grants Priority Review for Enfortumab Vedotin Biologics License Application in Locally Advanced or Metastatic Urothelial Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 25 Jul 2019
U.S. FDA Accepts Correvio's Resubmitted New Drug Application For Brinavess (vernakalant)
Biopharmaceuticals Cardiology FDA

HSMN NewsFeed - 22 Jul 2019
Vanda Pharmaceuticals FDA Update for HETLIOZ(R) in the Treatment of Jet Lag Disorder
Biopharmaceuticals FDA

HSMN NewsFeed - 23 May 2019
Nektar Announces the Launch of Inheris Biopharma, Inc.
Biopharmaceuticals Personnel

HSMN NewsFeed - 4 Apr 2019
Daiichi Sankyo Provides Update on Ongoing FDA Review for Quizartinib for Treatment of Patients with Relapsed/Refractory FLT3-ITD AML
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 11 Mar 2019
Eisai and Imbrium Therapeutics Announce U.S. FDA Filing Acceptance of New Drug Application for Lemborexant for the Treatment of Insomnia
Biopharmaceuticals FDA

HSMN NewsFeed - 11 Mar 2019
Allergan Announces FDA Acceptance of New Drug Application for Ubrogepant for the Acute Treatment of Migraine
Biopharmaceuticals FDA

HSMN NewsFeed - 7 Mar 2019
FDA Accepts Supplemental Biologics License Applications (sBLAs) for BOTOX(R) (onabotulinumtoxinA) for Pediatric Patients with Upper and Lower Limb Spasticity
Biopharmaceuticals FDA

HSMN NewsFeed - 4 Mar 2019
Important New Trial With Oral FERACCRU(R) Shows Comparable Efficacy to IV Iron (Ferric Carboxymaltose), Offering a Real Alternative to Hospital Administration for Many Patients[4]
Biopharmaceuticals

HSMN NewsFeed - 11 Feb 2019
FDA Grants Orphan Drug Designation to Amplyx Pharmaceuticals for APX001 for Treatment of Cryptococcosis
Biopharmaceuticals FDA

HSMN NewsFeed - 31 Dec 2018
FDA Grants Priority Review Designation for Heron Therapeutics' NDA for HTX-011, a Non-Opioid for Postoperative Pain Management
Biopharmaceuticals Surgery FDA

HSMN NewsFeed - 20 Dec 2018
FDA Accepts HETLIOZ(R) (tasimelteon) Supplemental New Drug Application for Review in the Treatment of Jet Lag Disorder
Biopharmaceuticals FDA

HSMN NewsFeed - 29 Nov 2018
FDA Accepts Filing of New Estrogen-free Oral Contraceptive Developed by Exeltis
Biopharmaceuticals FDA

HSMN NewsFeed - 13 Nov 2018
Sobi(TM) to Acquire Synagis(R) US Rights From AstraZeneca - Creates a Platform for Global Growth
Biopharmaceuticals Acquisitions

HSMN NewsFeed - 9 Nov 2018
Jazz Pharmaceuticals Submits Marketing Authorization Application to European Medicines Agency for Solriamfetol as a Treatment to Improve Wakefulness and Reduce Excessive Daytime Sleepiness in Adult Patients with Narcolepsy or Obstructive Sleep Apnea
Biopharmaceuticals Regulatory

HSMN NewsFeed - 12 Oct 2018
Rockwell Medical Provides Update on IV Triferic
Biopharmaceuticals FDA

HSMN NewsFeed - 8 Oct 2018
U.S. FDA Announces Joint Advisory Committee Review of Mallinckrodt's Abuse-Deterrent, Immediate-Release Reformulation of Roxicodone(R) (Oxycodone Hydrochloride)
Biopharmaceuticals Drug Delivery FDA

HSMN NewsFeed - 12 Sep 2018
FDA to Review Supplemental Biologics License Application for Praluent(R) (alirocumab)Injection as Potential Treatment to Reduce Major Adverse Cardiovascular Events
Biopharmaceuticals Cardiology FDA

HSMN NewsFeed - 5 Jul 2018
New England Journal of Medicine Publishes Results from Pivotal Study of TEGSEDI(TM) (inotersen) for the Treatment of Hereditary ATTR Amyloidosis
Biopharmaceuticals Neurology

HSMN NewsFeed - 27 Jun 2018
Revive Therapeutics Announces FDA Grants Orphan Drug Designation for Cannabidiol in the Treatment of Autoimmune Hepatitis
Biopharmaceuticals FDA

HSMN NewsFeed - 27 Jun 2018
AcelRx receives European Commission approval for DZUVEO(TM)
Biopharmaceuticals Drug Delivery Regulatory

HSMN NewsFeed - 29 May 2018
U.S. FDA Grants Priority Review to Astellas' New Drug Application for Gilteritinib for the Treatment of Adult Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML)
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 9 May 2018
DURECT Announces Amendment to Licensing Agreement with Sandoz Related to POSIMIR(R) (SABER(R)-Bupivacaine)
Biopharmaceuticals Drug Delivery Surgery Licensing

HSMN NewsFeed - 27 Apr 2018
Amgen Receives Positive CHMP Opinion To Expand Use Of Prolia(R) (denosumab) To Patients With Glucocorticoid-Induced Osteoporosis
Biopharmaceuticals Regulatory

HSMN NewsFeed - 20 Apr 2018
FDA Accepts Veloxis's Supplemental New Drug Application for the De Novo Indication for ENVARSUS XR(R)
Biopharmaceuticals FDA

HSMN NewsFeed - 5 Mar 2018
U.S. FDA Accepts New Drug Application for Prucalopride (SHP555) for Chronic Idiopathic Constipation
Biopharmaceuticals Gastroenterology FDA

HSMN NewsFeed - 2 Mar 2018
Jazz Pharmaceuticals Announces FDA Acceptance of NDA for Solriamfetol (JZP-110) for Excessive Sleepiness Associated with Narcolepsy or Obstructive Sleep Apnea
Biopharmaceuticals FDA

HSMN NewsFeed - 23 Feb 2018
Mallinckrodt Receives FDA Acceptance of Stannsoporfin New Drug Application Filing
Biopharmaceuticals FDA

HSMN NewsFeed - 9 Feb 2018
Salix Provides Update on FDA Submission for PLENVU(R)
Biopharmaceuticals Gastroenterology FDA

HSMN NewsFeed - 1 Feb 2018
Partner Therapeutics (PTx) Acquires Leukine(R) from Sanofi
Biopharmaceuticals Oncology Acquisitions

HSMN NewsFeed - 29 Jan 2018
Theravance Biopharma and Mylan Announce FDA Acceptance of New Drug Application for Revefenacin (TD-4208) in Adults with Chronic Obstructive Pulmonary Disease
Biopharmaceuticals FDA

HSMN NewsFeed - 18 Jan 2018
Aquestive Therapeutics Announces U.S. FDA Filing Acceptance of New Drug Application for Clobazam Oral Soluble Film to Treat Lennox-Gastaut Syndrome
Biopharmaceuticals Neurology Drug Delivery FDA

HSMN NewsFeed - 4 Jan 2018
Acacia Pharma Announces FDA Acceptance of NDA Filing For BAREMSIS(R) for the Management of Post-operative Nausea & Vomiting
Biopharmaceuticals FDA

HSMN NewsFeed - 29 Dec 2017
Progenics Pharmaceuticals Announces FDA Acceptance of New Drug Application for AZEDRA(R) (iobenguane I 131) in Pheochromocytoma and Paraganglioma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 28 Dec 2017
GW Pharmaceuticals Announces Acceptance of NDA Filing for Epidiolex(R) (cannabidiol) in the treatment of Lennox-Gastaut syndrome and Dravet syndrome
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 11 Dec 2017
Regeneron Announces FDA Acceptance of sBLA Filing for 12-Week Dosing of EYLEA(R) (aflibercept) Injection for Patients with Wet AMD
Biopharmaceuticals Ophthalmology FDA

HSMN NewsFeed - 27 Oct 2017
AbbVie Receives U.S. FDA Priority Review for Investigational Oral Treatment Elagolix for the Management of Endometriosis with Associated Pain
Biopharmaceuticals FDA

HSMN NewsFeed - 10 Oct 2017
Allergan Announces that the FDA Accepts New Drug Application for Ulipristal Acetate for Uterine Fibroids
Biopharmaceuticals FDA

HSMN NewsFeed - 9 Aug 2017
Ocugen Receives FDA Orphan Drug Designation for OCU300 (brimonidine tartrate) for the Treatment of Ocular Graft Versus Host Disease
Biopharmaceuticals Ophthalmology FDA

HSMN NewsFeed - 1 Aug 2017
AcelRx Pharmaceuticals Reports Successful Outcome of ZALVISO Phase 3 IAP312 Study on Device Functionality
Biopharmaceuticals Drug Delivery

HSMN NewsFeed - 28 Jul 2017
FDA Grants Priority Review For Amgen's Supplemental Biologics License Application For Repatha(R) (evolocumab) To Include Data On Reducing Risk Of Cardiovascular Events
Biopharmaceuticals Cardiology FDA

HSMN NewsFeed - 20 Jul 2017
Churchill Pharmaceuticals Announces NDA Filing Acceptance for YONSA(TM) by the U.S. FDA
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 19 Jul 2017
AcelRx Pharmaceuticals Appoints Raffi Asadorian as Chief Financial Officer
Biopharmaceuticals Personnel

HSMN NewsFeed - 30 Jun 2017
BioMarin Submits Pegvaliase Biologics License Application (BLA) to the U.S. FDA for Treatment of Phenylketonuria (PKU)
Biopharmaceuticals FDA

HSMN NewsFeed - 19 Jun 2017
FDA Accepts Amgen's Supplemental Biologics License Application To Expand Indication For XGEVA(R) (denosumab) To Include Multiple Myeloma Patients
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 19 Jun 2017
FDA Accepts Rigel's New Drug Application for TAVALISSE(TM) (fostamatinib disodium) for the Treatment of Chronic ITP
Biopharmaceuticals FDA

HSMN NewsFeed - 23 May 2017
Ultragenyx Announces Recombinant Human Beta-Glucuronidase Biologics License Application and Marketing Authorization Application Filed and Accepted for Review; FDA Grants Priority Review Status
Biopharmaceuticals FDA

HSMN NewsFeed - 28 Apr 2017
Regeneron and Sanofi Announce Kevzara(R) (sarilumab) Biologics License Application Resubmission Accepted for Review by U.S. FDA
Biopharmaceuticals FDA

HSMN NewsFeed - 7 Apr 2017
Flexion Therapeutics Announces Appointment of Yamo Deniz, MD, as Chief Medical Officer
Biopharmaceuticals Personnel

HSMN NewsFeed - 2 Mar 2017
EnGeneIC Receives FDA Orphan Drug Designation for Targeted EDV(TM) Nanocells to Treat Glioblastoma Multiforme
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 3 Feb 2017
Intellipharmaceutics Announces FDA Acceptance for Filing of NDA for Rexista(TM) (oxycodone hydrochloride extended release), an Abuse Deterrent Opioid Analgesic for the Treatment of Moderate to Severe Pain
Biopharmaceuticals FDA

HSMN NewsFeed - 19 Jan 2017
Ezra Announces FDA Acceptance Of Filing Of New Drug Application For EZR-104 For The Treatment Of Hypertension And Heart Failure
Biopharmaceuticals Cardiology FDA

HSMN NewsFeed - 3 Jan 2017
Marinus Pharmaceuticals Receives FDA Orphan Drug Designation for Ganaxolone to Treat Fragile X Syndrome
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 8 Dec 2016
Regeneron and Sanofi Announce Marketing Authorization Application for Dupixent(R) (dupilumab) Accepted for Review by the EMA
Biopharmaceuticals Dermatology Regulatory

HSMN NewsFeed - 30 Nov 2016
Neurocrine Announces FDA Advisory Committee Meeting to Review INGREZZA(TM) (valbenazine) New Drug Application for the Treatment of Tardive Dyskinesia
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 11 Oct 2016
Neurocrine Announces INGREZZA(TM) (valbenazine) New Drug Application for the Treatment of Tardive Dyskinesia has been Accepted for Priority Review by U.S. FDA
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 26 Sep 2016
Regeneron and Sanofi Announce Dupilumab Biologics License Application Accepted for Priority Review by U.S. FDA
Biopharmaceuticals Dermatology FDA

HSMN NewsFeed - 5 Sep 2016
Dynavax Provides Regulatory Update on HEPLISAV-B
Biopharmaceuticals FDA

HSMN NewsFeed - 1 Jul 2016
Valeant Pharmaceuticals Announces New Licensing Arrangement For Brodalumab In Europe
Biopharmaceuticals Licensing

HSMN NewsFeed - 30 Jun 2016
OPKO Health to Acquire Transition Therapeutics
Biopharmaceuticals Mergers & Acquisitions

HSMN NewsFeed - 9 Jun 2016
Bradley Campbell, President and COO of Amicus Therapeutics, elected to Progenics Board of Directors
Biopharmaceuticals Oncology Personnel

HSMN NewsFeed - 24 May 2016
Allergan Announces FDA Acceptance of NDA Filing for Oxymetazoline HCI Cream 1.0%
Biopharmaceuticals Dermatology FDA

HSMN NewsFeed - 19 May 2016
Pain Therapeutics Announces FDA Advisory Committee Meeting for REMOXY(R)
Biopharmaceuticals FDA

HSMN NewsFeed - 16 May 2016
Pfizer to Acquire Anacor
Biopharmaceuticals Mergers & Acquisitions

HSMN NewsFeed - 9 May 2016
Elite Pharmaceuticals to Present SequestOx(TM) Data at the American Pain Society 35th Annual Scientific Meeting
Biopharmaceuticals Drug Delivery

HSMN NewsFeed - 29 Mar 2016
Pain Therapeutics Resubmits REMOXY New Drug Application to the U.S. Food and Drug Administration
Biopharmaceuticals Drug Delivery FDA

HSMN NewsFeed - 28 Mar 2016
Aralez Announces FDA Acceptance of New Drug Application for YOSPRALA(TM)
Biopharmaceuticals Cardiology FDA

HSMN NewsFeed - 17 Mar 2016
Elite Announces U.S. FDA Priority Review Designation for SequestOx(TM) NDA
Biopharmaceuticals FDA

HSMN NewsFeed - 1 Mar 2016
FLAG Therapeutics Announces the Granting of Orphan Drug Designation to FLAG-003 in both the US and EU for the Treatment of Glioma
Biopharmaceuticals Oncology FDA Regulatory

HSMN NewsFeed - 29 Feb 2016
Egalet Announces FDA Acceptance of New Drug Application for ARYMO(TM) ER (Morphine Sulfate) Extended-Release Tablets
Biopharmaceuticals Drug Delivery FDA

HSMN NewsFeed - 10 Feb 2016
Amarantus Receives Orphan Drug Designation From the US FDA for Eltoprazine in the Treatment of Parkinson's Disease Levodopa-Induced Dyskinesia
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 25 Jan 2016
Valeant Announces FDA Acceptance of BLA Submission for Brodalumab in Moderate-to-Severe Plaque Psoriasis
Biopharmaceuticals Dermatology FDA

HSMN NewsFeed - 19 Jan 2016
Thetis Receives Orphan Drug Designation for TP-252 in Familial Adenomatous Polyposis
Biopharmaceuticals FDA

HSMN NewsFeed - 29 Dec 2015
Amarantus Requests Rare Pediatric Disease and Orphan Drug Designations from US FDA for Engineered Skin Substitute in the Treatment of Giant Congenital Melanocytic Nevi
Devices Regenerative Medicine Dermatology FDA

HSMN NewsFeed - 19 Nov 2015
Triphase Accelerator Corporation Announces FDA Orphan Drug Designation for Marizomib in Malignant Glioma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 18 Nov 2015
Otonomy Initiates Patient Enrollment in U.S. Phase 3 Clinical Trial of OTO-104 in Meniere's Disease
Biopharmaceuticals

HSMN NewsFeed - 15 Oct 2015
Teikoku Pharma USA and Eagle Pharmaceuticals Enter into License Agreement for Docetaxel, Non-Alcohol Formula
Biopharmaceuticals Oncology Licensing

HSMN NewsFeed - 12 Oct 2015
Heron Therapeutics Appoints Neil J. Clendeninn, M.D., Ph.D. as Senior Vice President and Chief Medical Officer
Biopharmaceuticals Personnel

HSMN NewsFeed - 5 Oct 2015
Otonomy Receives FDA Clearance of Investigational New Drug Application for Tinnitus Product Candidate, OTO-311
Biopharmaceuticals FDA

HSMN NewsFeed - 31 Aug 2015
FDA Grants Priority Review for Intercept's Obeticholic Acid for the Treatment of Primary Biliary Cirrhosis
Biopharmaceuticals FDA

HSMN NewsFeed - 24 Aug 2015
Chiasma Appoints William H. Ludlam, M.D., Ph.D., as Vice President of Medical Affairs
Biopharmaceuticals Endocrinology Personnel

HSMN NewsFeed - 21 May 2015
Tris Pharma Announces the FDA Acceptance of NDA for Dyanavel(TM) XR
Biopharmaceuticals Drug Delivery

HSMN NewsFeed - 15 May 2015
Zambon Launches Xadago(R) (safinamide) for Patients with Mid- to Late-Stage Parkinson’s Disease in Germany
Biopharmaceuticals Neurology Product Launch

HSMN NewsFeed - 18 Mar 2015
Selten Pharma, Inc. Receives Orphan Drug Designation From U.S. FDA for the Treatment of Pulmonary Arterial Hypertension
Biopharmaceuticals FDA

HSMN NewsFeed - 27 Feb 2015
FDA Advisory Committee Recommends Approval for Avedro’s Riboflavin Ophthalmic Solutions with UVA Irradiation for Corneal Collagen Cross-Linking to Treat Progressive Keratoconus and Corneal Ectasia
Biopharmaceuticals Ophthalmology FDA

HSMN NewsFeed - 26 Jan 2015
Regeneron and Sanofi Announce Praluent(TM) (alirocumab) Biologics License Application has Been Accepted for Priority Review by US FDA
Biopharmaceuticals FDA

HSMN NewsFeed - 27 Oct 2014
Aeterna Zentaris Announces Formal Implementation of its Sales Force In Support of Selling ASCEND's EstroGel(R)
Biopharmaceuticals Distribution

HSMN NewsFeed - 27 Aug 2014
European Commission Approves Bristol-Myers Squibb’s Daklinza (daclatasvir) Across Multiple Genotypes for the Treatment of Chronic Hepatitis C Infection
Biopharmaceuticals Regulatory

HSMN NewsFeed - 5 Aug 2014
Aeterna Zentaris and ASCEND Therapeutics Sign Co-Promotion Agreement for U.S. Market
Biopharmaceuticals Distribution

HSMN NewsFeed - 27 Jun 2014
Bristol-Myers Squibb Receives Positive CHMP Opinion for Daklinza(R) (daclatasvir) for Treatment of Chronic Hepatitis C in the European Union
Biopharmaceuticals Regulatory

HSMN NewsFeed - 10 Jun 2014
Avanir Pharmaceuticals Announces Positive Outcome of Phase IIIb COMPASS Trial: A Head-to-Head Study Comparing AVP-825 to Oral Sumatriptan for the Acute Treatment of Migraine
Biopharmaceuticals

HSMN NewsFeed - 5 Jun 2014
ORBACTIV(TM) (Oritavancin) Phase 3 Trial Results Published in New England Journal of Medicine
Biopharmaceuticals

HSMN NewsFeed - 21 May 2014
Baxter Provides U.S. Regulatory Update on HyQvia, Its Investigational Subcutaneous Treatment for Primary Immunodeficiency
Biopharmaceuticals FDA

HSMN NewsFeed - 21 May 2014
Clarus Therapeutics Appoints Patrick Shea Chief Commercial Officer
Biopharmaceuticals Personnel

HSMN NewsFeed - 1 May 2014
Dr. Edward Rudnic Appointed CEO of QRxPharma
Biopharmaceuticals Personnel

HSMN NewsFeed - 14 Apr 2014
Alimera Sciences Announces New PDUFA Date For ILUVIEN(R)
Biopharmaceuticals Ophthalmology

HSMN NewsFeed - 25 Mar 2014
AcelRx Pharmaceuticals Appoints Timothy E. Morris as Chief Financial Officer
Biopharmaceuticals Personnel

HSMN NewsFeed - 6 Feb 2014
Spectrum Pharmaceuticals Announces FDA’s Acceptance of NDA Filing for Beleodaq(TM) (belinostat) for Injection, a novel pan-HDAC inhibitor
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 30 Jan 2014
Chelsea Therapeutics Names Keith W. Schmidt Chief Commercial Officer
Biopharmaceuticals Neurology Personnel

HSMN NewsFeed - 21 Jan 2014
Keryx Biopharmaceuticals Announces Appointment of Daniel W. Olmstead as Vice President, Payer Access
Biopharmaceuticals Personnel

HSMN NewsFeed - 30 Dec 2013
Cubist Announces FDA Acceptance of Tedizolid New Drug Application with Priority Review
Biopharmaceuticals FDA

HSMN NewsFeed - 18 Dec 2013
Regeneron Announces FDA Acceptance of EYLEA(R) (aflibercept) Injection Supplemental Biologics License Application for Review for Diabetic Macular Edema Indication
Biopharmaceuticals Ophthalmology FDA

HSMN NewsFeed - 16 Dec 2013
AcelRx and Grunenthal Announce Collaboration for EU Commercialization of ZALVISO(TM)
Biopharmaceuticals Drug Delivery

HSMN NewsFeed - 3 Dec 2013
BioDelivery Sciences Announces Hiring of David Acheson as Vice President of Sales and Managed Markets
Biopharmaceuticals Drug Delivery Personnel

HSMN NewsFeed - 25 Nov 2013
Auxilium Pharmaceuticals Presented New Analyses of XIAFLEX(R) Peyronie's Disease Data at SMSNA Scientific Meeting
Biopharmaceuticals Urology

HSMN NewsFeed - 12 Nov 2013
A.P. Pharma Announces Pipeline Expansion
Biopharmaceuticals Drug Delivery Oncology

HSMN NewsFeed - 27 Sep 2013
DURECT Announces Changes to its Board of Directors
Biopharmaceuticals Drug Delivery Personnel

HSMN NewsFeed - 16 Sep 2013
Actinium Pharmaceuticals Appoints Kaushik J. Dave, Ph.D., MBA As President, Chief Executive Officer And Director
Biopharmaceuticals Oncology Personnel

HSMN NewsFeed - 6 Sep 2013
U.S. Food and Drug Administration Approves ABRAXANE(R) in Combination with Gemcitabine as First-Line Treatment of Patients with Metastatic Pancreatic Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 28 Aug 2013
Auxilium Receives Notification of XIAFLEX(R) PDUFA Extension
Biopharmaceuticals FDA

HSMN NewsFeed - 20 Jun 2013
DURECT Announces FDA Acceptance of New Drug Application (NDA) Submission for POSIDUR(R) (SABER(R)-Bupivacaine)
Biopharmaceuticals Drug Delivery FDA

HSMN NewsFeed - 28 Feb 2013
A.P. Pharma Appoints Jesse Hollingsworth as Vice President of Sales
Biopharmaceuticals Drug Delivery Personnel

HSMN NewsFeed - 23 Jan 2013
Allergan, Inc. to Acquire MAP Pharmaceuticals, Inc.
Biopharmaceuticals Neurology Mergers & Acquisitions

HSMN NewsFeed - 7 Jan 2013
Auxilium Pharmaceuticals, Inc. Announces Expansion of Its Exclusive License for XIAFLEX(R) (CCH) to Include the Potential Treatment of Cellulite as an Additional Indication
Biopharmaceuticals

HSMN NewsFeed - 27 Dec 2012
U.S. Food and Drug Administration Accepts XIAFLEX(R) Supplemental Biologics License Application Filing for the Treatment of Peyronie's Disease
Biopharmaceuticals Urology

HSMN NewsFeed - 26 Dec 2012
ELIQUIS(R) (apixaban) Approved In Japan For The Prevention Of Stroke And Systemic Embolism In Patients With Nonvalvular Atrial Fibrillation
Biopharmaceuticals Cardiology Regulatory

HSMN NewsFeed - 14 Dec 2012
The CHMP Delivers a Positive Opinion Recommending Grant of Marketing Authorization for ADASUVE(R) (Staccato(R) Loxapine) in the European Union
Biopharmaceuticals Regulatory

HSMN NewsFeed - 13 Dec 2012
A.P. Pharma Names Mark S. Gelder, M.D. as Senior Vice President and Chief Medical Officer
Biopharmaceuticals Personnel

HSMN NewsFeed - 26 Nov 2012
Zogenix Appoints New Chief Commercial Officer
Biopharmaceuticals Neurology Personnel

HSMN NewsFeed - 8 Nov 2012
Zogenix Announces FDA Advisory Committee Review of Zohydro(TM) ER for the Management of Chronic Pain
Biopharmaceuticals FDA

HSMN NewsFeed - 29 Oct 2012
Bayer's Stivarga(R) (regorafenib) Tablets New Drug Application Granted Priority Review by U.S. FDA for the Treatment of Patients with Gastrointestinal Stromal Tumors
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 18 Oct 2012
A.P. Pharma Appoints Robert Rosen as Senior Vice President and Chief Commercial Officer
Biopharmaceuticals Drug Delivery Personnel

HSMN NewsFeed - 29 Aug 2012
U.S. FDA Grants Priority Review of ZYTIGA(R) (abiraterone acetate) sNDA for Treatment of Metastatic Castration-Resistant Prostate Cancer Before Chemotherapy
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 28 Aug 2012
Dynavax Announces FDA Advisory Committee to Review HEPLISAV(TM)
Biopharmaceuticals FDA

HSMN NewsFeed - 10 Jul 2012
Dynavax Appoints David Happel Vice President, Global Sales and Marketing
Biopharmaceuticals Personnel

HSMN NewsFeed - 10 Jul 2012
Human Genome Sciences Announces Resubmission of Raxibacumab BLA to FDA
Biopharmaceuticals FDA

HSMN NewsFeed - 22 May 2012
Talon Therapeutics Appoints Head of Commercial Operations and Planning
Biopharmaceuticals Drug Delivery Oncology Personnel

HSMN NewsFeed - 26 Apr 2012
Onyx Pharmaceuticals Announces FDA Advisory Committee to Review Carfilzomib for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 13 Mar 2012
Cornerstone Therapeutics Receives FDA Acceptance for CRTX 080 NDA for Treatment of Hyponatremia
Biopharmaceuticals

HSMN NewsFeed - 8 Mar 2012
Regeneron and Bayer Announce Approval of EYLEA(R) (aflibercept) Injection for the Treatment of Wet Age-Related Macular Degeneration in Australia
Biopharmaceuticals Ophthalmology Regulatory

HSMN NewsFeed - 2 Mar 2012
Arena Pharmaceuticals Files European Marketing Authorization Application for Lorcaserin for Weight Control
Biopharmaceuticals Regulatory

HSMN NewsFeed - 21 Feb 2012
Pliaglis(R) Regulatory Update
Biopharmaceuticals

HSMN NewsFeed - 15 Feb 2012
FDA Accepts Pfizer’s New Drug Application for Tafamidis Meglumine, a Novel, Investigational Treatment for Transthyretin Familial Amyloid Polyneuropathy (TTR-FAP)
Biopharmaceuticals Neurology

HSMN NewsFeed - 15 Feb 2012
Santarus Announces FDA Acceptance of UCERIS New Drug Application for Induction of Remission of Active Ulcerative Colitis
Biopharmaceuticals Gastroenterology

HSMN NewsFeed - 30 Jan 2012
Cell Therapeutics Withdraws New Drug Application for Pixuvri™ and Plans to Resubmit in 2012
Biopharmaceuticals Oncology

HSMN NewsFeed - 8 Nov 2011
Lilly and Amylin Mutually Agree to End Diabetes Alliance and Transition Exenatide Responsibility to Amylin
Biopharmaceuticals

HSMN NewsFeed - 14 Sep 2011
ApoPharma Announces FDA Advisory Committee Recommendation in Favor of Ferriprox(R) (deferiprone) Approval
Biopharmaceuticals FDA

HSMN NewsFeed - 30 Aug 2011
Progenics and Salix Announce FDA Acceptance of sNDA Filing for RELISTOR(R) in Patients with Non-Cancer Pain
Biopharmaceuticals FDA

HSMN NewsFeed - 11 Jul 2011
Watson and Antares Announce Exclusive License Agreement for Antares' Oxybutynin Gel Product (Anturol(R))
Biopharmaceuticals Licensing

HSMN NewsFeed - 30 Jun 2011
FDA Accepts Submission of New Drug Application for CORLUX for Cushing's Syndrome
Biopharmaceuticals FDA

HSMN NewsFeed - 17 Jun 2011
Seattle Genetics Announces Promotion of Eric Dobmeier to Chief Operating Officer
Biopharmaceuticals Personnel

HSMN NewsFeed - 3 May 2011
Optimer Pharmaceuticals Expands Senior Management Team
Biopharmaceuticals Personnel

HSMN NewsFeed - 8 Apr 2011
Antares Pharma Announces FDA Acceptance of Anturol(R) NDA for Filing
Biopharmaceuticals Urology

HSMN NewsFeed - 22 Mar 2011
FDA Accepts for Review Spectrum Pharmaceuticals’ ZEVALIN(R) Submission for the Removal of the Bioscan
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 21 Mar 2011
Phase III Study of Investigational Compound Ipilimumab Achieves Primary Endpoint of Improvement in Overall Survival in Previously-Untreated Patients with Metastatic Melanoma
Biopharmaceuticals Oncology

HSMN NewsFeed - 14 Feb 2011
Optimer Pharmaceuticals Appoints Glenn Tillotson, Ph.D., to Senior Vice President of Medical Affairs and Announces Executive Promotions
Biopharmaceuticals Personnel

HSMN NewsFeed - 27 Jan 2011
REMOXY New Drug Application Accepted by FDA
Biopharmaceuticals Pain Management

HSMN NewsFeed - 22 Dec 2010
Delcath Completes New Drug Application Submission to the FDA for the Chemosaturation Delivery System
Biopharmaceuticals Devices Drug Delivery Oncology FDA

HSMN NewsFeed - 7 Dec 2010
Orexigen(R) Therapeutics' Investigational Drug Contrave(R) Receives Positive Recommendation from FDA Advisory Committee for Treatment of Obesity
Biopharmaceuticals FDA

HSMN NewsFeed - 2 Dec 2010
US FDA Advisory Committee Makes Recommendation on New Drug Application for Vandetanib in Advanced Medullary Thyroid Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 29 Nov 2010
Pfizer and Protalix BioTherapeutics Announce Submission of taliglucerase alfa for European Marketing Authorization for the Treatment of Gaucher Disease
Biopharmaceuticals Regulatory

HSMN NewsFeed - 7 Sep 2010
Protalix BioTherapeutics Names Tzvi Palash Chief Operating Officer
Biopharmaceuticals Personnel

HSMN NewsFeed - 19 Aug 2010
Human Genome Sciences and GlaxoSmithKline Announce FDA Priority Review Designation for BENLYSTA(R) (belimumab) as a Potential Treatment for Systemic Lupus Erythematosus
Biopharmaceuticals FDA

HSMN NewsFeed - 12 Aug 2010
Darl Moreland Joins Alexza Pharmaceuticals as Vice President, Quality
Biopharmaceuticals Personnel

HSMN NewsFeed - 22 Jul 2010
Alexza Pharmaceuticals Appoints Joseph L. Turner to Its Board of Directors
Biopharmaceuticals Personnel

HSMN NewsFeed - 14 Jul 2010
Aeterna Zentaris Announces Perifosine Has Received Orphan-Drug Designation for the Treatment of Neuroblastoma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 1 Jul 2010
Eisai to Market Arena Pharmaceuticals' Lorcaserin for Obesity and Weight Management in U.S. Following FDA Approval
Biopharmaceuticals

HSMN NewsFeed - 1 Jul 2010
Eisai Inc. Enters Marketing and Supply Agreement with Arena Pharmaceuticals for Lorcaserin
Biopharmaceuticals

HSMN NewsFeed - 26 May 2010
Staccato(R) Loxapine (AZ-004) Reduced Signs and Symptoms of Agitation as Early as Ten Minutes After Dosing in Patients with Schizophrenia or Bipolar Disorder
Biopharmaceuticals

HSMN NewsFeed - 25 May 2010
Genzyme Receives FDA Approval for Lumizyme for Pompe Disease
Biopharmaceuticals FDA

HSMN NewsFeed - 13 May 2010
NicOx provides update on FDA Advisory Committee Meeting for naproxcinod
Biopharmaceuticals FDA

HSMN NewsFeed - 2 Mar 2010
InterMune Announces Submission of MAA for Pirfenidone for the Treatment of Patients With IPF
Biopharmaceuticals Regulatory

HSMN NewsFeed - 1 Mar 2010
FDA Accepts VIAject(R) NDA for Review
Biopharmaceuticals Endocrinology FDA

HSMN NewsFeed - 1 Mar 2010
ADVENTRX Receives Refuse to File Letter from FDA on ANX-530 New Drug Application
Biopharmaceuticals

HSMN NewsFeed - 26 Feb 2010
Arena Pharmaceuticals Receives PDUFA Date for Lorcaserin NDA
Biopharmaceuticals FDA

HSMN NewsFeed - 20 Feb 2010
FDA Classifies Prolia(TM) (Denosumab) Complete Response Submission and Targets Action Date
Biopharmaceuticals FDA

HSMN NewsFeed - 18 Jan 2010
Theratechnologies Reports Date for FDA Advisory Committee Review of the Tesamorelin New Drug Application
Biopharmaceuticals HIV/AIDS FDA

HSMN NewsFeed - 15 Jan 2010
FDA Extends Review Period for Tarceva Application for First-Line Maintenance Use in Advanced Non-Small Cell Lung Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 30 Dec 2009
Pfizer Provides U.S. Regulatory Update On Prevnar 13 Vaccine
Biopharmaceuticals FDA

HSMN NewsFeed - 24 Dec 2009
FDA Accepts for Review Questcor's Filing of Its Supplemental New Drug Application for H.P. Acthar(R) Gel for Treatment of Infantile Spasms
Biopharmaceuticals FDA

HSMN NewsFeed - 22 Dec 2009
Shire Submits Biologics License Application (BLA) for REPLAGAL(R) With the U.S. Food and Drug Administration (FDA)
Biopharmaceuticals

HSMN NewsFeed - 21 Dec 2009
European Medicines Agency Grants Cell Therapeutics Orphan Drug Designation for Pixantrone in Diffuse Large B-Cell Lymphoma (DLBCL)
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 17 Dec 2009
Cell Therapeutics Announces FDA's Oncologic Drugs Advisory Committee to Review Pixantrone for the Treatment of Relapsed/Refractory Aggressive Non-Hodgkin's Lymphoma, February 10, 2010
Biopharmaceuticals Oncology

HSMN NewsFeed - 27 Nov 2009
Theravance Receives Complete Response Letter on the Telavancin NDA for the Treatment of Nosocomial Pneumonia
Biopharmaceuticals FDA

HSMN NewsFeed - 16 Nov 2009
OSI Pharmaceuticals Announces Tarceva to Be Reviewed by the FDA's Oncologic Drugs Advisory Committee for Use as a First-Line Maintenance Therapy in Advanced Non-Small Cell Lung Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 5 Nov 2009
NeurogesX Expands Commercial Operations Leadership Team
Biopharmaceuticals Personnel

HSMN NewsFeed - 16 Sep 2009
U.S. Food and Drug Administration's Arthritis Advisory Committee Votes Unanimously 12-0 to Recommend Approval of XIAFLEX(TM) for Dupuytren's Contracture
Biopharmaceuticals

HSMN NewsFeed - 16 Sep 2009
Keryx Biopharmaceuticals Receives Orphan-Drug Designation for KRX-0401 (Perifosine) for the Treatment of Multiple Myeloma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 2 Sep 2009
FDA Advisory Committee Recommends Gloucester Pharmaceuticals' Romidepsin for Approval for Cutaneous T-cell Lymphoma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 1 Aug 2009
New Data from Phase III SATURN Study Showed Tarceva Extended Survival in Patients with Advanced Non-Small Cell Lung Cancer When Used Immediately after Initial Chemotherapy
Biopharmaceuticals Oncology

HSMN NewsFeed - 31 Jul 2009
U.S. Food and Drug Administration's Arthritis Advisory Committee Confirms Date to Review XIAFLEX(TM) for the Treatment of Dupuytren's Contracture
Biopharmaceuticals FDA

HSMN NewsFeed - 17 Jul 2009
NeurogesX Announces Resignation of Bruce A. Peacock from Board of Directors
Biopharmaceuticals Personnel

HSMN NewsFeed - 13 Jul 2009
New Data from Phase III SATURN Study Showed Tarceva Improved Overall Survival When Used Immediately After Initial Chemotherapy in Patients with Advanced Non-Small Cell Lung Cancer
Biopharmaceuticals Oncology

HSMN NewsFeed - 2 Jul 2009
CombinatoRx and Neuromed Sign Merger Agreement
Biopharmaceuticals Mergers & Acquisitions Personnel

HSMN NewsFeed - 1 Jul 2009
Biogen Idec and Acorda Therapeutics Announce Collaboration Agreement to Develop and Commercialize MS Therapy Fampridine-SR in Markets Outside the U.S.
Biopharmaceuticals Neurology Licensing

HSMN NewsFeed - 22 Jun 2009
NeurogesX and Astellas Enter Commercialization Agreement for Qutenza(TM)
Biopharmaceuticals Drug Delivery Distribution

HSMN NewsFeed - 18 Jun 2009
U.S. Food and Drug Administration's Arthritis Advisory Committee Sets Tentative Date to Review XIAFLEX(TM) for the Treatment of Dupuytren's Contracture
Biopharmaceuticals FDA

HSMN NewsFeed - 17 Jun 2009
Neuromed Announces Sale of U.S. Rights to Drug Candidate Exalgo(TM) (hydromorphone HCl) Extended-Release Tablets (CII) to Mallinckrodt
Biopharmaceuticals

HSMN NewsFeed - 16 Jun 2009
FDA Appointed Arthritis Advisory Committee Recommends U.S. Food and Drug Administration Approval for KRYSTEXXA(TM) for Refractory Chronic Gout
Biopharmaceuticals

HSMN NewsFeed - 10 Jun 2009
NeurogesX Provides U.S. Regulatory Update for Qutenza(TM)
Biopharmaceuticals Drug Delivery FDA

HSMN NewsFeed - 10 Jun 2009
Strativa's New Drug Application for Ondansetron Orally Dissolving Film Strip Accepted by FDA
Biopharmaceuticals Drug Delivery FDA

HSMN NewsFeed - 2 Jun 2009
NeurogesX Receives FDA Orphan Drug Designation for Qutenza(TM) for Treatment of Postherpetic Neuralgia
Biopharmaceuticals Drug Delivery FDA

HSMN NewsFeed - 21 May 2009
NeurogesX Receives European Commission Approval for Qutenza(TM)
Biopharmaceuticals Drug Delivery Regulatory

HSMN NewsFeed - 5 May 2009
Pervasis Therapeutics Granted Orphan Drug Designation for Vascugel
Biopharmaceuticals Regenerative Medicine FDA

HSMN NewsFeed - 28 Apr 2009
XIAFLEX(TM) for the Treatment of Dupuytren's Contracture Receives Priority Review From the U.S. Food and Drug Administration
Biopharmaceuticals FDA

HSMN NewsFeed - 23 Apr 2009
U.S. Food and Drug Administration Extends Review Timeline for ONGLYZA (saxagliptin) New Drug Application
Biopharmaceuticals Endocrinology FDA

HSMN NewsFeed - 2 Apr 2009
Xanodyne's New Drug Application for the Treatment of Heavy Menstrual Bleeding (Menorrhagia) Accepted for Filing with a Priority Review Classification
Biopharmaceuticals FDA

HSMN NewsFeed - 25 Mar 2009
Transcept Pharmaceuticals Appoints Joseph T. Kennedy as General Counsel
Biopharmaceuticals Personnel

HSMN NewsFeed - 16 Mar 2009
Spectrum Pharmaceuticals Acquires 100% of ZEVALIN, an FDA-Approved, Proprietary, Biological Drug for Non-Hodgkin's Lymphoma
Biopharmaceuticals Oncology Acquisitions

HSMN NewsFeed - 25 Feb 2009
ARCA biopharma Appoints Kathryn Falberg as Chief Financial Officer and Chief Operating Officer
Biopharmaceuticals Personnel

HSMN NewsFeed - 23 Feb 2009
Spectrum Pharmaceuticals Poised to Acquire 100% Interest in RIT Oncology LLC Joint Venture upon CTI's Fulfillment of Closing Conditions
Biopharmaceuticals Oncology Acquisitions

HSMN NewsFeed - 19 Feb 2009
FDA Accepts Nuvo's Resubmission For Pennsaid(R)
Biopharmaceuticals Drug Delivery FDA

HSMN NewsFeed - 10 Feb 2009
Dyax and Fovea Sign Development and Commercialization Agreement for DX-88 in Ophthalmic Indications
Biopharmaceuticals Ophthalmology

HSMN NewsFeed - 4 Feb 2009
FDA Advisory Committee Favors Approval of DX-88 for Acute Attacks of Hereditary Angioedema
Biopharmaceuticals FDA

HSMN NewsFeed - 3 Feb 2009
FDA Grants Priority Review of a Supplemental Biologics License Application for Cinryze(TM) C1 Inhibitor (Human) as Treatment for Acute Attacks of Hereditary Angioedema (HAE)
Biopharmaceuticals FDA

HSMN NewsFeed - 2 Feb 2009
Transcept Pharmaceuticals, Inc. Completes Merger with Novacea, Inc.
Biopharmaceuticals Mergers & Acquisitions

HSMN NewsFeed - 29 Jan 2009
FDA Accepts Eurand's Response to Approvable Letter for EUR-1008 as Complete
Biopharmaceuticals FDA

HSMN NewsFeed - 27 Jan 2009
Novacea Stockholders Approve Merger With Transcept
Biopharmaceuticals Mergers & Acquisitions

HSMN NewsFeed - 9 Jan 2009
Anesiva Announces FDA Approval of Supplemental New Drug Application to Expand Zingo(TM) Indication
Biopharmaceuticals Drug Delivery FDA

HSMN NewsFeed - 5 Jan 2009
Prism Pharmaceuticals Receives FDA Approval of NEXTERONE(R) for Life-Threatening Ventricular Fibrillation and Ventricular Tachycardia
Biopharmaceuticals Cardiology

HSMN NewsFeed - 16 Dec 2008
Cell Therapeutics and Spectrum Pharmaceuticals Close Transaction Forming Joint Venture to Market Zevalin in the US
Biopharmaceuticals Oncology

HSMN NewsFeed - 8 Dec 2008
Forest Laboratories, Inc. and Cypress Bioscience, Inc. Announce Positive Results of Phase III Study of Milnacipran for the Management of Fibromyalgia
Biopharmaceuticals

HSMN NewsFeed - 1 Dec 2008
FDA Accepts Cell Therapeutics' Zevalin sBLA and Grants Priority Review
Biopharmaceuticals Oncology

HSMN NewsFeed - 22 Oct 2008
NeurogesX Submits NDA for NGX-4010 Dermal Capsaicin Patch for Treatment of Postherpetic Neuralgia (PHN)
Biopharmaceuticals Drug Delivery FDA

HSMN NewsFeed - 25 Sep 2008
Acusphere, Inc. Appoints Michael Slater SVP Regulatory Affairs and Operations Replacing Dennis Bucceri
Biopharmaceuticals Personnel

HSMN NewsFeed - 4 Sep 2008
EPIX Pharmaceuticals To Regain Full Worldwide Commercial Rights For Vasovist(R)
Biopharmaceuticals Radiology

HSMN NewsFeed - 18 Aug 2008
Somaxon Pharmaceuticals Announces the Appointment of Senior Commercial Leadership
Biopharmaceuticals Personnel

HSMN NewsFeed - 7 Aug 2008
Somaxon Pharmaceuticals Appoints Richard W. Pascoe as President and Chief Executive Officer
Biopharmaceuticals Personnel

HSMN NewsFeed - 28 Jul 2008
Arpida Submits Marketing Authorisation Application for Intravenous Iclaprim in Europe
Biopharmaceuticals

HSMN NewsFeed - 30 Jun 2008
Acusphere Announces FDA Acceptance of Imagify(TM) NDA for Detection of Coronary Artery Disease
Biopharmaceuticals Cardiology FDA

HSMN NewsFeed - 30 Jun 2008
Anesiva Launches Needle-Free Zingo(TM) to Reduce Pain from IV Starts and Blood Draws in Children
Biopharmaceuticals Devices Drug Delivery

HSMN NewsFeed - 10 Jun 2008
Pain Therapeutics and King Pharmaceuticals Announce Submission of New Drug Application for Remoxy
Biopharmaceuticals

HSMN NewsFeed - 4 Jun 2008
Indevus Pharmaceuticals Provides Update on NEBIDO(R) NDA Status
Biopharmaceuticals FDA

HSMN NewsFeed - 31 May 2008
VELCADE(R) (Bortezomib) for Injection Based Treatment Delivers Impressive Complete Response and Survival in Patients With Newly Diagnosed Multiple Myeloma
Biopharmaceuticals Oncology

HSMN NewsFeed - 9 May 2008
Adolor Provides Regulatory Update on Entereg(R) (alvimopan)
Biopharmaceuticals

HSMN NewsFeed - 24 Apr 2008
Wyeth and Progenics Receive Positive Opinion From European Committee for RELISTOR for the Treatment of Opioid-Induced Constipation in Advanced-Illness Patients
Biopharmaceuticals Regulatory

HSMN NewsFeed - 22 Apr 2008
Archemix' ARC1779 Granted Orphan Designation for the Treatment of TTP, a Life-Threatening Blood Disorder
Biopharmaceuticals FDA

HSMN NewsFeed - 1 Apr 2008
Wyeth and Progenics Announce RELISTOR Receives Canadian Marketing Approval
Biopharmaceuticals Regulatory

HSMN NewsFeed - 27 Mar 2008
Discovery Labs Adds Two Executives to Its Management Team
Biopharmaceuticals Personnel

HSMN NewsFeed - 18 Mar 2008
Immunomedics' Milatuzumab Receives FDA Orphan Drug Designation for Therapy of Multiple Myeloma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 5 Mar 2008
FDA Accepts for Review Theravance's Complete Response to Approvable Letter for Telavancin for the Treatment of Complicated Skin and Skin Structure Infections
Biopharmaceuticals FDA

HSMN NewsFeed - 8 Feb 2008
FDA Extends Review of NDA for ENTEREG(R) (alvimopan)
Biopharmaceuticals FDA

HSMN NewsFeed - 31 Jan 2008
Somaxon Pharmaceuticals Submits New Drug Application for SILENOR(TM) for the Treatment of Insomnia
Biopharmaceuticals

HSMN NewsFeed - 23 Jan 2008
Adolor and GlaxoSmithKline Report Favorable FDA Advisory Committee Meeting for ENTEREG(R) (alvimopan) for the Management of Postoperative Ileus in Bowel Resection
Biopharmaceuticals

HSMN NewsFeed - 23 Jan 2008
NovaDel's New Drug Application for ZolpiMist(TM) Oral Spray to Treat Insomnia Accepted for Filing by the U.S. Food and Drug Administration
Biopharmaceuticals Drug Delivery FDA

HSMN NewsFeed - 22 Jan 2008
Indevus Reports Additional Positive Phase III Trial Data for NEBIDO(R)
Biopharmaceuticals

HSMN NewsFeed - 21 Jan 2008
Cardiome And Astellas Announce Regulatory Update
Biopharmaceuticals FDA

HSMN NewsFeed - 14 Dec 2007
Neurochem announces European opinion for Eprodisate (KIACTA(TM)) for the treatment of AA amyloidosis
Biopharmaceuticals Regulatory

HSMN NewsFeed - 12 Dec 2007
VIVUS Initiates Third Qnexa Phase 3 Trial in Obese Patients
Biopharmaceuticals

HSMN NewsFeed - 7 Dec 2007
FDA Reviewing Potential Anti-Arrhythmic Claims for Ranexa(R)
Biopharmaceuticals Cardiology

HSMN NewsFeed - 7 Dec 2007
DOR BioPharma Announces Results of orBec(R) End of Review Conference With the FDA
Biopharmaceuticals FDA

HSMN NewsFeed - 16 Nov 2007
VIVUS Initiates Second Qnexa Pivotal Phase 3 Trial in Obese Patients
Biopharmaceuticals

HSMN NewsFeed - 1 Nov 2007
FDA Accepts New Drug Application for NEBIDO(R) Submitted by Indevus
Biopharmaceuticals Endocrinology FDA

HSMN NewsFeed - 15 Oct 2007
Abraxis Bioscience Reaches Agreement with the FDA Following Special Protocol Assessment for Phase III Trial of ABRAXANE in Non-Small Cell Lung Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 9 Oct 2007
orBec(R) Clinical Summary Published in "Expert Opinion on Investigational Drugs"
Biopharmaceuticals

HSMN NewsFeed - 21 Sep 2007
BIO Celebrates Senate Passage of PDUFA Reauthorization Package
Biopharmaceuticals FDA

HSMN NewsFeed - 20 Sep 2007
FDA Accepts New Drug Application for Priority Review of Investigational HIV Treatment TMC125
Biopharmaceuticals HIV/AIDS FDA

HSMN NewsFeed - 10 Sep 2007
BrainStorm Cell Therapeutics Takes Initial Steps Toward FDA Submission
Regenerative Medicine Neurology

HSMN NewsFeed - 4 Sep 2007
MGI PHARMA and HELSINN Announce Aloxi(R) sNDA Approval Allowing for Repeated Dosing for Cancer Patients Receiving Multiple Day Chemotherapy Regimens
Biopharmaceuticals FDA

HSMN NewsFeed - 29 Aug 2007
Wyeth and Progenics Submit Marketing Application in Australia for Subcutaneous Methylnaltrexone
Biopharmaceuticals Regulatory

HSMN NewsFeed - 28 Aug 2007
FDA Accepts for Review Complete Response to Approvable Letter for Entereg(R) (alvimopan) for POI
Biopharmaceuticals Surgery FDA

HSMN NewsFeed - 17 Aug 2007
Anesiva Receives FDA Approval for Zingo(TM), a New, Innovative Product to Reduce Pain Associated with Needle Insertion Procedures in Children
Biopharmaceuticals Drug Delivery FDA

HSMN NewsFeed - 15 Aug 2007
Noven Completes Acquisition of JDS Pharmaceuticals
Biopharmaceuticals Mergers & Acquisitions

HSMN NewsFeed - 7 Aug 2007
GammaCan Receives FDA Orphan Drug Designation for Lead Product VitiGam(TM) for Stage IIB to Stage IV Melanoma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 6 Aug 2007
Indevus Announces FDA Approval of SANCTURA(R) XR
Biopharmaceuticals Urology FDA

HSMN NewsFeed - 25 Jul 2007
Kuvan Receives Priority Review Status from FDA
Biopharmaceuticals

HSMN NewsFeed - 10 Jul 2007
Noven to Acquire JDS Pharmaceuticals, Expanding Business Model & Broadening Product Pipeline
Biopharmaceuticals Mergers & Acquisitions

HSMN NewsFeed - 27 Jun 2007
Taxotere(R) (docetaxel) Granted FDA Priority Review for Treatment of Locally Advanced Squamous Cell Carcinoma of the Head and Neck Prior to Chemoradiotherapy and Surgery
Biopharmaceuticals FDA Oncology

HSMN NewsFeed - 20 Jun 2007
Merck Provides Update on Status of Supplemental Biologics License Applications (sBLA) for GARDASIL(R)
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 19 Jun 2007
ZymoGenetics Establishes Global Collaboration With Bayer HealthCare for Development and Commercialization of Recombinant Human Thrombin
Biopharmaceuticals Licensing

HSMN NewsFeed - 13 Jun 2007
FDA Advisory Committee Did Not Recommend Approval of Rimonabant (ZIMULTI(R)) for Use in Obese and Overweight Patients With Associated Risks Factors
Biopharmaceuticals FDA Endocrinology

HSMN NewsFeed - 31 May 2007
Progenics and Wyeth Announce FDA Has Accepted For Filing the New Drug Application for Subcutaneous Methylnaltrexone
Biopharmaceuticals Regulatory

HSMN NewsFeed - 22 May 2007
Advancis Pharmaceutical Announces FDA Acceptance of Amoxicillin PULSYS NDA
Biopharmaceuticals Drug Delivery FDA

HSMN NewsFeed - 21 May 2007
Gilead Announces Presentation of Long-Term Data for Ambrisentan, a Potential Treatment for Patients With Pulmonary Arterial Hypertension
Biopharmaceuticals

HSMN NewsFeed - 16 May 2007
KV Pharmaceutical Company Completes Acquisition of U.S. Rights to EvaMist(TM)
Biopharmaceuticals Drug Delivery Licensing

HSMN NewsFeed - 16 May 2007
VIVUS Closes EvaMist Transaction with KV Pharmaceutical
Biopharmaceuticals Drug Delivery Licensing

HSMN NewsFeed - 15 May 2007
Spectrum Pharmaceuticals Announces FDA'S Oncology Drug Advisory Committee to Review Satraplatin for the Treatment of Hormone Refractory Prostate Cancer
Biopharmaceuticals Oncology

HSMN NewsFeed - 9 May 2007
FDA Advisory Panel Reviews DOR BioPharma's orBec(R) for Treatment of GI GVHD
Biopharmaceuticals FDA

HSMN NewsFeed - 2 May 2007
Critical Therapeutics' Co-Promotion Partner, DEY, L.P., Launches U.S. Sales and Marketing of ZYFLO(R) for Asthma
Biopharmaceuticals

HSMN NewsFeed - 23 Apr 2007
Pharmacyclics Announces FDA Filing of New Drug Application for Xcytrin(R) Injection to Treat Lung Cancer Brain Metastases
Biopharmaceuticals Oncology

HSMN NewsFeed - 17 Apr 2007
Merck Submits New Cross-Protection Data for GARDASIL(R) to the FDA and Seeks New Indications for Vaginal and Vulvar Cancers
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 16 Apr 2007
FDA Accepts Satraplatin NDA And Grants Priority Review
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 11 Apr 2007
Neurochem's eprodisate (KIACTA(TM)) PDUFA date extended three months by FDA
Biopharmaceuticals FDA

HSMN NewsFeed - 4 Apr 2007
DOR BioPharma Announces Initiation of Clinical Development Program for Oral Leuprolide
Biopharmaceuticals Drug Delivery Oncology

HSMN NewsFeed - 30 Mar 2007
KV Pharmaceutical Company Acquires U.S. Rights to EvaMist(TM) - A Novel New Product for the Treatment of the Symptoms of Menopause
Biopharmaceuticals Acquisitions

HSMN NewsFeed - 30 Mar 2007
VIVUS Agrees to Sell EvaMist Rights to KV Pharmaceutical
Biopharmaceuticals Acquisitions

HSMN NewsFeed - 29 Mar 2007
BIO Provides Key Principles on Follow-On Biologics to Legislators
Biopharmaceuticals Generics

HSMN NewsFeed - 28 Mar 2007
Anesiva Commences Phase 3 Clinical Study of Zingo(TM) to Treat Pain Associated With Venous Access Procedures in Adults
Biopharmaceuticals

HSMN NewsFeed - 23 Mar 2007
Advancis Pharmaceutical Resubmits New Drug Application for Once-Daily Amoxicillin PULSYS
Biopharmaceuticals

HSMN NewsFeed - 20 Mar 2007
DOR BioPharma Forms orBec(R) Medical Advisory Board
Biopharmaceuticals Personnel

HSMN NewsFeed - 16 Mar 2007
Endo and Vernalis plc Announce Three-Month Extension of PDUFA Date for Frova(R) sNDA
Biopharmaceuticals FDA

HSMN NewsFeed - 14 Mar 2007
Critical Therapeutics and DEY, L.P. Enter into Co-Promotion Agreement for Respiratory Care Products
Biopharmaceuticals

HSMN NewsFeed - 14 Mar 2007
Napo Obtains IRB Approval for Phase 3 Clinical Trial Protocol for Crofelemer In HIV/AIDS Diarrhea Assessment
Biopharmaceuticals HIV/AIDS

HSMN NewsFeed - 7 Mar 2007
ZymoGenetics Provides Update on rhThrombin Development Plans
Biopharmaceuticals

HSMN NewsFeed - 28 Feb 2007
Advancis Pharmaceutical Reaches Agreement with FDA for Resubmission of Amoxicillin PULSYS NDA
Biopharmaceuticals FDA

HSMN NewsFeed - 23 Feb 2007
Pro-Pharmaceuticals Meeting Scheduled with the FDA
Biopharmaceuticals Oncology

HSMN NewsFeed - 20 Feb 2007
Hana Biosciences Reports Likely Delay in Launch of Zensana(TM)
Biopharmaceuticals

HSMN NewsFeed - 16 Feb 2007
Inspire Licenses AzaSite(TM) For Ocular Infections
Biopharmaceuticals Ophthalmology Licensing

HSMN NewsFeed - 7 Feb 2007
Anesiva Announces FDA Acceptance for Filing of Zingo(TM) New Drug Application to Reduce Pain Associated With Needle Insertion Procedures in Children
Biopharmaceuticals

HSMN NewsFeed - 31 Jan 2007
FDA Advisory Committee to Review DOR BioPharma's orBec(R) for the Treatment of GI GVHD
Biopharmaceuticals FDA

HSMN NewsFeed - 16 Jan 2007
Tercica Reports Somatuline(R) Autogel(R) NDA for Acromegaly Accepted for Filing by FDA
Biopharmaceuticals FDA

HSMN NewsFeed - 15 Jan 2007
Lux Biosciences Receives Orphan Drug Designation from the FDA for Two Ophthalmic Products
Biopharmaceuticals Ophthalmology FDA

HSMN NewsFeed - 8 Jan 2007
Provectus Receives Orphan Drug Designation from FDA for Anti-Cancer Agent PV-10 for the Treatment Of Metastatic Melanoma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 4 Jan 2007
Boston Life Sciences Acquires Rights to Develop and Commercialize Promising Phase II Spinal Cord Injury Drug, Cethrin(R), in Exclusive Worldwide License
Biopharmaceuticals Neurology Licensing

HSMN NewsFeed - 20 Dec 2006
Labopharm submits response to approvable letter for once-daily Tramadol to FDA
Biopharmaceuticals FDA

HSMN NewsFeed - 13 Dec 2006
FDA Accepts New Drug Application for SANCTURA XR(TM) Submitted by Indevus
Biopharmaceuticals Urology

HSMN NewsFeed - 12 Dec 2006
Indevus Pharmaceuticals to Acquire Valera Pharmaceuticals
Biopharmaceuticals Mergers & Acquisitions

HSMN NewsFeed - 7 Dec 2006
Cephalon Provides Update Related to Final NUVIGIL(TM) Labeling
Biopharmaceuticals FDA

HSMN NewsFeed - 28 Nov 2006
European Medicines Agency Accepts DOR BioPharma's MAA Filing for orBec(R)
Biopharmaceuticals Regulatory

HSMN NewsFeed - 21 Nov 2006
FDA Accepts DOR BioPharma's NDA Filing for orBec(R)
Biopharmaceuticals Gastroenterology FDA

HSMN NewsFeed - 15 Nov 2006
Critical Therapeutics Announces Efficacy Data for Controlled-Release Formulation of Zileuton Presented at ACAAI 2006 Annual Meeting
Biopharmaceuticals

HSMN NewsFeed - 8 Nov 2006
Bradley Pharmaceuticals Enters Into Agreement With BioSante Pharmaceuticals for Estradiol Transdermal Gel
Biopharmaceuticals

HSMN NewsFeed - 26 Oct 2006
Millennium and Ortho Biotech Enter into U.S. Co-Promotion Agreement for VELCADE(R)(bortezomib) for Injection
Biopharmaceuticals Oncology

HSMN NewsFeed - 17 Oct 2006
Critical Therapeutics Announces Acceptance of Controlled-Release Zileuton New Drug Application for Review by FDA
Biopharmaceuticals FDA

HSMN NewsFeed - 12 Oct 2006
Agennix Receives FDA Orphan Drug Designation for Talactoferrin Alfa in Renal Cell Carcinoma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 10 Oct 2006
MacroGenics Receives Orphan Drug Designation From FDA for Monoclonal Antibody to Treat Type 1 Diabetes
Biopharmaceuticals Endocrinology FDA

HSMN NewsFeed - 6 Oct 2006
Genta Receives Special Protocol Assessment from FDA for Randomized Trial of Genasense(R) Plus Chemotherapy in Chronic Lymphocytic Leukemia
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 26 Sep 2006
Millennium Agrees to Acquire AnorMED, Adding Phase III Oncology Product with Planned Near Term Launch Date
Biopharmaceuticals Mergers & Acquisitions

HSMN NewsFeed - 26 Sep 2006
Callisto Pharmaceuticals Granted Orphan Drug Designation for Atiprimod to Treat Carcinoid Tumors
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 19 Sep 2006
FDA Approves Connetics' Verdeso Foam for the Treatment of Mild-to-Moderate Atopic Dermatitis
Biopharmaceuticals Dermatology Drug Delivery FDA

HSMN NewsFeed - 6 Jul 2006
FDA Accepts Adeza NDA Filing for Gestiva to Prevent Preterm Births
Biopharmaceuticals FDA

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