Healthcare Sales & Marketing Network: FDA : Medical Device and Pharmaceutical News

Healthcare News Roundup: FDA

HSMN NewsFeed - 28 Feb 2008
CAS Medical Systems, Inc. Announces FDA 510(k) Clearance for Neonatal FORE-SIGHT Cerebral Oximeter
Devices Monitoring FDA

HSMN NewsFeed - 28 Feb 2008
FDA Issues Not-Approvable Letter for Lilly's Zyprexa(R) Long-Acting Injection (LAI) for Schizophrenia Treatment
Biopharmaceuticals FDA

HSMN NewsFeed - 28 Feb 2008
Kyowa Hakko Receives Not Approvable Letter from FDA for Istradefylline (KW-6002)
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 27 Feb 2008
FDA Approves Regeneron's ARCALYST(TM) (rilonacept) for Treatment of Cryopyrin-Associated Periodic Syndromes (CAPS)
Biopharmaceuticals FDA

HSMN NewsFeed - 27 Feb 2008
APP Pharmaceuticals Receives Final Approval for Irinotecan Hydrochloride Injection
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 27 Feb 2008
FDA Clears Cellsearch(TM) Circulating Tumor Cell Test for Monitoring Metastatic Prostate Cancer Patients
Diagnostics FDA

HSMN NewsFeed - 27 Feb 2008
FDA Accepts for Review OVATION's Two NDA Submissions for Sabril(R)
Biopharmaceuticals Neurology

HSMN NewsFeed - 27 Feb 2008
Covidien Announces Tentative FDA Approval for Its Generic Myocardial Perfusion Imaging Kit
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 26 Feb 2008
Cayenne Medical Receives FDA Approval for iFix(TM) PEEK Interference Screw System
Devices Orthopaedic FDA

HSMN NewsFeed - 25 Feb 2008
Diazyme Introduces New Test for the Early Detection of Kidney Disease
Diagnostics FDA

HSMN NewsFeed - 25 Feb 2008
Boston Scientific Announces Three FDA Product Approvals for Its Cardiac Rhythm Management Business
Devices Cardiology FDA

HSMN NewsFeed - 23 Feb 2008
FDA Grants Accelerated Approval of Avastin in Combination With Paclitaxel Chemotherapy for First-Line Treatment of Advanced HER2-Negative Breast Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 22 Feb 2008
Abbott Receives FDA Approval for HUMIRA(R) (Adalimumab) for Polyarticular Juvenile Idiopathic Arthritis
Biopharmaceuticals FDA

HSMN NewsFeed - 22 Feb 2008
Cardima Announces Appointment of Dr. Sanjeev Saksena to Scientific Advisory Board as FDA Regulatory Consultant
Devices Cardiology Personnel

HSMN NewsFeed - 22 Feb 2008
Adherex Receives Orphan Drug Designation for ADH-1 in Melanoma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 22 Feb 2008
Kiadis Pharma Obtains FDA Approval to Start a Phase III Clinical Trial for Reviroc(TM) in the United States
Biopharmaceuticals Oncology

HSMN NewsFeed - 21 Feb 2008
Wyeth's XYNTHA Approved by FDA for Treatment of Hemophilia A
Biopharmaceuticals FDA

HSMN NewsFeed - 20 Feb 2008
GSK Receives Favorable Recommendation by FDA Advisory Committee for Rotarix(R) (Rotavirus Vaccine, Live, Oral)
Biopharmaceuticals FDA

HSMN NewsFeed - 20 Feb 2008
Kensey Nash Receives FDA 510(k) Clearance for New Safe-Cross(R) Vessel Wall Detection Technology
Devices Interventional FDA

HSMN NewsFeed - 19 Feb 2008
Barr Receives Final Approval for Generic Mirapex(R) Tablets, 0.125mg, 0.25mg, 0.5mg, 1mg & 1.5mg
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 19 Feb 2008
Pyng Medical Receives US FDA Clearance
Devices FDA

HSMN NewsFeed - 19 Feb 2008
FDA Accepts TREANDA(R) New Drug Application for the Treatment of Relapsed Indolent Non-Hodgkin's Lymphoma
Biopharmaceuticals Oncology

HSMN NewsFeed - 19 Feb 2008
diaDexus Receives FDA Clearance for Automated Blood Test That Identifies Stroke & Heart Attack Risk
DIagnostics Cardiology FDA

HSMN NewsFeed - 19 Feb 2008
FDA Approves XYZAL(R) (levocetirizine dihydrochloride) Oral Solution for the Relief of Seasonal and Year Round Allergies and Chronic Idiopathic Urticaria
Biopharmaceuticals FDA

HSMN NewsFeed - 18 Feb 2008
Given Imaging Receives NSE Letter From the U.S. Food and Drug Administration Regarding Its Application to Market PillCam(R) COLON
Devices Gastroenterology FDA

HSMN NewsFeed - 18 Feb 2008
Solvay Pharmaceuticals, Inc. Receives Fast Track Designation From U.S. Food and Drug Administration for Levodopa/Carbidopa Intestinal Gel for Advanced Parkinson's Disease
Biopharmaceuticals FDA Neurology

HSMN NewsFeed - 18 Feb 2008
Siemens Receives FDA Approval for the VERSANT 440 Molecular System
Diagnostics FDA

HSMN NewsFeed - 15 Feb 2008
Abbott Receives FDA Approval for SIMCOR(R) (Niaspan(R) / simvastatin), a Novel Combination Medicine for Comprehensive Cholesterol Management
Biopharmaceuticals Cardiology FDA

HSMN NewsFeed - 14 Feb 2008
St. Jude Medical Receives FDA and CE Mark Approvals of Extended 10-Year Battery Life Claim for Rechargeable Neurostimulator
Devices Neurology FDA Regulatory

HSMN NewsFeed - 14 Feb 2008
MethylGene and Pharmion Announce U.S. Orphan Drug Designation Granted for MGCD0103 for the Treatment of Acute Myelogenous Leukemia
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 14 Feb 2008
Pharmion and MethylGene Announce U.S. Orphan Drug Designation Granted for MGCD0103 for the Treatment of Acute Myelogenous Leukemia
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 12 Feb 2008
Natus Medical to Resume Domestic Shipments of Olympic Cool-Cap
Devices FDA Neurology

HSMN NewsFeed - 11 Feb 2008
Hi-Tech Pharmacal Receives Approval for Hydrocodone Bitartrate and Homatropine Methylbromide Syrup
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 11 Feb 2008
Cipher provides CIP-TRAMADOL ER regulatory update
Biopharmaceuticals FDA

HSMN NewsFeed - 8 Feb 2008
Solstice Neurosciences, Inc. Issues Corporate Response to FDA Early Communication
Biopharmaceuticals

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

HSMN NewsFeed - 8 Feb 2008
APP Pharmaceuticals Receives FDA Approval for Bleomycin Sulfate for Injection, USP
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 8 Feb 2008
APP Pharmaceuticals Receives FDA Approval for Caffeine Citrate Oral Solution, USP
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 7 Feb 2008
Volcano Announces FDA 510(k) Clearance of Revolution Rotational Catheter and FFR for the s5i Integrated IVUS Console
Devices FDA Interventional Cardiology

HSMN NewsFeed - 7 Feb 2008
CryoLife Receives FDA 510(k) Clearance for SynerGraft(R) Processed Human Pulmonary Heart Valves
Devices FDA Cardiology

HSMN NewsFeed - 7 Feb 2008
Ranbaxy Receives Tentative Approval to Manufacture and Market Esomeprazole Magnesium DR Capsules
Biopharmaceuticals FDA Generics

HSMN NewsFeed - 7 Feb 2008
Transdel Pharmaceuticals Submits to the FDA the Phase 3 Clinical Study of Ketotransdel(TM) for the Treatment of Acute Pain
Biopharmaceuticals Drug Delivery

HSMN NewsFeed - 7 Feb 2008
Life Spine Announces FDA Approval of Kinetic(R)-SL
Devices FDA Neurosurgery Orthopaedic

HSMN NewsFeed - 7 Feb 2008
Biolase Announces FDA 510(k) Clearance of Its Waterlase(R) MD Laser System for Dermatology
Devices FDA Dermatology

HSMN NewsFeed - 6 Feb 2008
FDA Advisory Committee Supports Efficacy and Safety of Zyprexa(R) Long-Acting Injection (LAI) for Schizophrenia Treatment
Biopharmaceuticals FDA

HSMN NewsFeed - 6 Feb 2008
Medtronic Receives U.S. FDA Approval for New Neurostimulator with Innovative Patient Programmer
Devices Neurology Pain Management FDA

HSMN NewsFeed - 6 Feb 2008
Barr Launches Generic Fosamax(R) Tablets, 70 mg
Biopharmaceuticals FDA Generics

HSMN NewsFeed - 6 Feb 2008
Teva Announces Approval of Generic Fosamax(R) Tablets, 5 mg, 10 mg, 35 mg, 40 mg and 70 mg
Biopharmaceuticals FDA Generics

HSMN NewsFeed - 6 Feb 2008
The Female Health Company Announces FDA Acceptance for Review of Its FC2 Premarket Approval Application
Devices FDA

HSMN NewsFeed - 6 Feb 2008
Ranbaxy Gains Approval to Manufacture and Market Cefuroxime Axetil for Oral Suspension
Biopharmaceuticals FDA Generics

HSMN NewsFeed - 6 Feb 2008
FDA Agrees to Review Cimzia(R) File for the Treatment of Rheumatoid Arthritis
Biopharmaceuticals FDA

HSMN NewsFeed - 5 Feb 2008
Insmed Launches National Awareness Campaign Surrounding Follow-On Biologics
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 5 Feb 2008
Insmed CEO Issues Statement on White House FY09 Budget and FDA Statements on Follow-On Biologics
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 5 Feb 2008
FDA Approves CytoCore's SoftPAP(TM) Cervical Cell Collector
Diagnostics FDA

HSMN NewsFeed - 4 Feb 2008
MedImmune Submits Biologics License Application to FDA for Motavizumab
Biopharmaceuticals

HSMN NewsFeed - 4 Feb 2008
FDA Approves ASMANEX (R) TWISTHALER(R) (Mometasone Furoate Inhalation Powder) for the Once Daily Maintenance Treatment of Asthma in Children Ages 4-11
Biopharmaceuticals FDA

HSMN NewsFeed - 4 Feb 2008
Centocor Announces Ustekinumab Biologic License Application Accepted for Filing by FDA
Biopharmaceuticals Dermatology FDA

HSMN NewsFeed - 1 Feb 2008
Medtronic Receives FDA Approval for Endeavor(R) Zotarolimus-Eluting Coronary Stent System
Devices Interventional Cardiology FDA

HSMN NewsFeed - 1 Feb 2008
Mylan Announces Final FDA Approval for Granisetron Hydrochloride Tablets
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 31 Jan 2008
IDEV Technologies Inc. Receives 510(k) Clearance for New SUPERA(TM) Biliary Stent Delivery Catheter
Devices Interventional FDA

HSMN NewsFeed - 31 Jan 2008
MedWaves, Inc. Announces Receipt of United States Food and Drug Administration 510k Clearance to Market Its Patented Microwave Coagulation/Ablation System
Devices Oncology FDA

HSMN NewsFeed - 31 Jan 2008
Teva Announces Tentative Approval of Generic Flomax(R) Capsules
Biopharmaceuticals Urology Generics FDA

HSMN NewsFeed - 31 Jan 2008
FDA Grants Priority Review for Schering-Plough's Peginterferon Alfa-2b for the Adjuvant Treatment of Patients With Stage III Melanoma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 31 Jan 2008
Ipsen: FDA Accepts for Filing a Biologics License Application (BLA) for Dysport(R) in Cervical Dystonia
Biopharmaceuticals

HSMN NewsFeed - 30 Jan 2008
Smiths Medical Receives 510(k) Clearance on Saf-T Closed Blood Collection System(R) Devices
Devices FDA

HSMN NewsFeed - 30 Jan 2008
Lux Granted Fast Track Designation for LX201 for Corneal Transplant Rejection
Biopharmaceuticals Ophthalmology Drug Delivery FDA

HSMN NewsFeed - 30 Jan 2008
IMPAX Receives FDA Non-Approvable Letter for Vadova(R); Company Considering Options
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 30 Jan 2008
FDA Grants Priority Review For Velcade(R) (bortezomib) for Injection In Patients with Newly Diagnosed Multiple Myeloma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 30 Jan 2008
Anesiva Announces Hiring of Sales Force for FDA-Approved Product Zingo(TM)
Biopharmaceuticals Drug Delivery

HSMN NewsFeed - 30 Jan 2008
Akorn, Inc. Announces FDA Approval of Calcitriol Injection, 1 mcg/mL and 2 mcg/mL
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 29 Jan 2008
FDA Approves EMEND(R) (fosaprepitant dimeglumine) for Injection, Merck's New Intravenous Therapy, for Use in Combination with Other Antiemetics for Prevention of Nausea and Vomiting Caused by Chemotherapy
Biopharmaceuticals FDA

HSMN NewsFeed - 29 Jan 2008
Escalon(R) Announces FDA 510(K) Clearance for VascuView(TM) Visual Ultrasound System For Assisted Vascular Access
Devices FDA

HSMN NewsFeed - 29 Jan 2008
Medtronic Announces FDA Approval of CGMS(R) iPRO(TM) Continuous Glucose Recorder
Devices Endocrinology FDA

HSMN NewsFeed - 29 Jan 2008
BioSante Pharmaceuticals Announces FDA Special Protocol Assessment (SPA) for LibiGel(R) in FSD
Biopharmaceuticals FDA

HSMN NewsFeed - 29 Jan 2008
Edwards Lifesciences Receives FDA Approval to Add Transapical Delivery System to U.S. Clinical Trial of Transcatheter Heart Valve
Devices Interventional Cardiology FDA

HSMN NewsFeed - 28 Jan 2008
Velcura Therapeutics, Inc. Can Begin Clinical Trials Following Successful Investigational New Drug Application to U.S. FDA
Biopharmaceuticals FDA

HSMN NewsFeed - 28 Jan 2008
FDA Grants Medtronic Approval to Begin Clinical Trial of First Pacemaker System Designed for Safe Use In MRI Machines
Devices Cardiology Radiology FDA

HSMN NewsFeed - 28 Jan 2008
Synta and GlaxoSmithKline Announce Elesclomol Granted Orphan Drug Designation by the FDA
Biopharmaceuticals FDA

HSMN NewsFeed - 28 Jan 2008
Toshiba Receives FDA Clearance for Vantage Titan MR System
Devices Radiology FDA

HSMN NewsFeed - 25 Jan 2008
ImaRx Therapeutics Receives Urokinase Lot Release Approval With Extended Expiration Dating
Biopharmaceuticals FDA

HSMN NewsFeed - 24 Jan 2008
Cook Incorporated Files IDE Application for Zenith Branch Vessel Graft with U.S. FDA
Devices Interventional FDA

HSMN NewsFeed - 24 Jan 2008
Labopharm Receives FDA Response To Recent Appeal Of Approvable Letter For Once-Daily Tramadol
Biopharmaceuticals FDA

HSMN NewsFeed - 24 Jan 2008
FDA Approves MiddleBrook's Amoxicillin PULSYS for Pharyngitis/Tonsillitis in Adolescents and Adults
Biopharmaceuticals FDA

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
Siemens Receives FDA 510(K) Clearance for Next Generation Radiation Therapy Solution
Devices Oncology FDA

HSMN NewsFeed - 23 Jan 2008
Teva Announces Tentative Approval of Generic Prevacid(R) Delayed-Release Capsules
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 23 Jan 2008
Mobius Therapeutics(TM) Granted Orphan Drug Designation
Biopharmaceuticals Drug Delivery Ophthalmology FDA

HSMN NewsFeed - 23 Jan 2008
The American Association of Clinical Endocrinologists (AACE) Strongly Supports the FDA in Its Concerns Regarding the Marketing and Use of So-Called Bio-Identical Hormones
Biopharmaceuticals. FDA

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 - 23 Jan 2008
Aragon Surgical LapCap Receives FDA Special 510(k) Clearance for Use With Longer Needles Used in Morbidly Obese Patients
Devices Surgery FDA

HSMN NewsFeed - 23 Jan 2008
FDA Approves Additional Indication for Astellas' MYCAMINE(R)
Biopharmaceuticals FDA

HSMN NewsFeed - 22 Jan 2008
St. Jude Medical Announces FDA Approval of Next Generation Internet-Based Data Management System for Implantable Cardiac Devices
Devices Cardiology FDA

HSMN NewsFeed - 22 Jan 2008
St. Jude Medical Announces FDA and European CE Mark Approval of the QuickFlex Family of Leads
Devices Cardiology FDA Regulatory

HSMN NewsFeed - 22 Jan 2008
Abiomed Receives HDE Supplement Approval for AbioCor(R) Artificial Heart
Devices Cardiology FDA

HSMN NewsFeed - 22 Jan 2008
Taro Receives FDA Approval of New Drug Application for Flo-Pred(TM) (Prednisolone Acetate Oral Suspension)
Biopharmaceuticals FDA

HSMN NewsFeed - 22 Jan 2008
FDA Approves Cheetah Reliant(TM) for Noninvasive Cardiac Output Monitoring (NICOM(R))
Devices Cardiology Monitoring FDA

HSMN NewsFeed - 22 Jan 2008
Stryker Issues Statement Regarding FDA Warning Letter
Devices Orthopaedic Product Recall FDA

HSMN NewsFeed - 22 Jan 2008
NovaBay Pharmaceutical's Investigational New Drug Application (IND) for the Prevention of Catheter Associated Urinary Tract Infections Cleared by FDA
Biopharmacuticals

HSMN NewsFeed - 22 Jan 2008
ImaRx and Microbix Sign Letter of Intent to Manufacture and Further Develop the FDA-Approved Clot-Dissolving Drug, Abbokinase(R)
Biopharmaceuticals

HSMN NewsFeed - 22 Jan 2008
Apthera Files a Phase III Special Protocol Assessment with FDA for NeuVax(TM) in Early-Stage Breast Cancer Patients
Biopharmaceuticals Oncology

HSMN NewsFeed - 21 Jan 2008
Welchol(TM) (colesevelam HCl) Receives FDA Approval to Reduce Blood Glucose in Adults With Type 2 Diabetes
Biopharmaceuticals Endocrinology FDA

HSMN NewsFeed - 21 Jan 2008
FDA Approves INTELENCE(TM) (etravirine) for HIV Combination Therapy
Biopharmaceuticals FDA HIV/AIDS

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

HSMN NewsFeed - 21 Jan 2008
US Approval for SPP100 Combined with Diuretic to Treat Hypertension
Biopharmaceuticals FDA

HSMN NewsFeed - 19 Jan 2008
FDA Approves INTELENCE(TM) (etravirine) for HIV Combination Therapy
Biopharmaceuticals HIV/AIDS FDA

HSMN NewsFeed - 19 Jan 2008
Abbott's HUMIRA(R) (adalimumab) Receives FDA Approval For Moderate to Severe Chronic Plaque Psoriasis
Biopharmaceuticals FDA

HSMN NewsFeed - 19 Jan 2008
Welchol(TM) (colesevelam HCl) Receives FDA Approval to Reduce Blood Glucose in Adults with Type 2 Diabetes
Biopharmaceuticals Endocrinology FDA

HSMN NewsFeed - 18 Jan 2008
Abbott Announces Approval of First Fully Automated Blood Screening Test for HTLV-I/HTLV-II
Diagnostics FDA

HSMN NewsFeed - 18 Jan 2008
Novagali Pharma Announces FDA Clearance of IND for US Clinical Trial of Nova63035 in Patients With Diabetic Macular Edema
Biopharmaceuticals Ophthalmology FDA

HSMN NewsFeed - 17 Jan 2008
FDA Approves ZymoGenetics' RECOTHROM(TM) Thrombin, topical (Recombinant)
Biopharmaceuticals FDA

HSMN NewsFeed - 17 Jan 2008
St. Jude Medical Announces FDA and European CE Mark Approvals of Durata Defibrillation Lead
Devices Cardiology FDA Regulatory

HSMN NewsFeed - 17 Jan 2008
APP Pharmaceuticals Receives FDA Approval for Polymyxin B Sulfate for Injection, USP
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 17 Jan 2008
TyRx Pharma, Inc. Announces Food and Drug Administration (FDA) 510(k) Clearance of the AIGIS(Rx)(TM) Cardiac Rhythm Medical Device (CRMD) Anti-Bacterial Envelope, an Innovative Mesh Envelope Designed to Immobilize and Reduce Bacterial Infection of a Pacem
Devices Biopharmaceuticals FDA Cardiology

HSMN NewsFeed - 16 Jan 2008
FDA Grants Approval to Extend U.S. Enrollment and Clinical Trial
Devices Interventional Cardiology

HSMN NewsFeed - 16 Jan 2008
St. Jude Medical Announces U.S. Clearance for Cardiac Image Integration Software
Devices Cardiology FDA

HSMN NewsFeed - 16 Jan 2008
Hi-Tech Pharmacal Receives Final Approval for Fluticasone Propionate Nasal Spray, 50mcg
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 16 Jan 2008
Aperio Receives FDA Clearance for Manual Read of HER2 Digital Slides
Diagnostics FDA

HSMN NewsFeed - 16 Jan 2008
ALVESCO(R) Gains FDA Approval for the U.S. Market
Biopharmaceuticals FDA

HSMN NewsFeed - 15 Jan 2008
Stereotaxis Announces FDA Approval of Its Partnered Magnetic Irrigated Catheter
Devices Cardiology FDA

HSMN NewsFeed - 15 Jan 2008
Fully Automated, Irrigated Tip Radiofrequency Ablation System with Remote Navigation Receives FDA Approval
Devices Cardiology FDA

HSMN NewsFeed - 15 Jan 2008
NitroMed Reports on BiDil XR(TM) Progress Following FDA Meeting, Announces Restructuring and Suspension of BiDil(R) Sales Force, and Retains Investment Bank to Advise on Strategic Options
Biopharmaceuticals

HSMN NewsFeed - 15 Jan 2008
Smiths Medical Receives FDA Clearance for Expansion of Power Injectable Port Line Including a New Arm Port
Devices Drug Delivery FDA

HSMN NewsFeed - 15 Jan 2008
POZEN Submits Human Lymphocyte Study for Treximet(TM) (Formerly Known as Trexima(TM))
Biopharmaceuticals FDA

HSMN NewsFeed - 15 Jan 2008
Orthovita Submits 510(k) Application to FDA for the Use of CORTOSS(R) Bone Augmentation Material in Vertebral Augmentation
Devices Orthopaedic Neurosurgery

HSMN NewsFeed - 14 Jan 2008
FDA Approves TYSABRI(R) for the Treatment of Moderate-to-Severe Crohn's Disease
Biopharmaceuticals FDA Gastroenterology

HSMN NewsFeed - 14 Jan 2008
Teva Announces Tentative Approval of Generic Aricept(R) Tablets
Biopharmaceuticals Generics FDA Neurology

HSMN NewsFeed - 14 Jan 2008
Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Metaglip(R)
Biopharmaceuticals Endocrinology Generics FDA

HSMN NewsFeed - 14 Jan 2008
Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic OTC Versions of Children's Zyrtec(R) Chewable Tablets for Allergy Relief and Children's Zyrtec(R) Chewable Tablets for Hives Relief
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 14 Jan 2008
King Pharmaceuticals Reports FDA Approval of Revised Labeling Regarding Purity of THROMBIN-JMI(R)
Biopharmaceuticals FDA

HSMN NewsFeed - 11 Jan 2008
Breckenridge Pharmaceutical Settles 'Paragraph IV' Litigation and Receives FDA Approval for its Oxcarbazepine ANDA
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 10 Jan 2008
FDA Accepts for Filing the BEMA(TM) Fentanyl NDA from BioDelivery Sciences
Biopharmaceuticals Drug Delivery

HSMN NewsFeed - 9 Jan 2008
Hemispherx Biopharma Addresses FDA Questions On Ampligen NDA
Biopharmaceuticals

HSMN NewsFeed - 8 Jan 2008
FDA Approves Cialis(R) (tadalafil) for Once Daily Use for the Treatment of Erectile Dysfunction
Biopharmaceuticals FDA

HSMN NewsFeed - 8 Jan 2008
Vion Pharmaceuticals Announces FDA Lift of Clinical Hold on Phase III Study of Cloretazine(R) (VNP40101M) and Cytarabine in Relapsed AML
Biopharmaceuticals Oncology

HSMN NewsFeed - 7 Jan 2008
BSD Medical Receives Letter from FDA on BSD-2000 Submission
Devices FDA

HSMN NewsFeed - 7 Jan 2008
Vision-Sciences, Inc. Receives FDA Clearance to Market the World's First Advanced Video-Based Cystoscopy Line for Use With Its New Generation EndoSheath Technology
Devices FDA

HSMN NewsFeed - 7 Jan 2008
Penumbra, Inc. Announces 510(k) Clearance of the Penumbra System(TM) for Use in the Revascularization of Patients With Acute Ischemic Stroke
Devices Neurology Interventional FDA

HSMN NewsFeed - 7 Jan 2008
Celldex Therapeutics Receives Fast-Track Designation for CDX-110, a Novel EGFRvIII Vaccine for Glioblastoma
Biopharmaceuticals FDA Oncology

HSMN NewsFeed - 7 Jan 2008
CoolTouch Introduces CoolLipo(TM) Laser System, Recently FDA Cleared for Laser-Assisted Lipolysis
Devices Dermatology FDA

HSMN NewsFeed - 4 Jan 2008
Creaspine's SupStance™ PEEK VBR gains FDA approval
Devices Neurosurgery Orthopaedic FDA

HSMN NewsFeed - 3 Jan 2008
Orphan Drug Designation Granted to OVATION's Clobazam for the Adjunctive Treatment of a Severe Form of Childhood Epilepsy
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 3 Jan 2008
Luminex Corporation Receives U.S. Food and Drug Administration Clearance for xTAG(TM) Respiratory Viral Panel
Diagnostics FDA

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