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Healthcare News Roundup: FDA

 HSMN NewsFeed - 8 Feb 2018
SIGA Technologies Announces FDA Accepts NDA and Grants Priority Review for Oral TPOXX to Treat Smallpox
Biopharmaceuticals FDA
 HSMN NewsFeed - 8 Feb 2018
N8 Medical Submits IDE for Breakthrough CeraShield(TM) Endotracheal Tube Device
Devices FDA
 HSMN NewsFeed - 8 Feb 2018
ZYTIGA(R) (abiraterone acetate) Plus Prednisone Approved for Treatment of Earlier Form of Metastatic Prostate Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 6 Feb 2018
Grifols HyperRAB(R) (rabies immune globulin [human]) 300 IU/mL Receives FDA Approval to Treat Patients Exposed to Rabies Virus Infection
Biopharmaceuticals FDA
 HSMN NewsFeed - 5 Feb 2018
FDA Clears Oricula Therapeutics Investigational New Drug Application for Clinical Trials
Biopharmaceuticals FDA
 HSMN NewsFeed - 5 Feb 2018
Trethera Corporation Announces FDA Clearance of Investigational New Drug Application for TRE-515
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 2 Feb 2018
FDA Approves AVYCAZ(R) (ceftazidime and avibactam) for the Treatment of Patients with Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia
Biopharmaceuticals FDA
 HSMN NewsFeed - 1 Feb 2018
Grünenthal Group Receives FDA's Expedited Access Pathway Designation for VIVO
Devices Surgery FDA
 HSMN NewsFeed - 30 Jan 2018
FDA Grants Orphan Drug Designation to Dauntless Pharmaceuticals' DP1038 for the Treatment of Acromegaly
Biopharmaceuticals FDA
 HSMN NewsFeed - 30 Jan 2018
Bracco Diagnostics Inc. receives U.S. Food and Drug Administration (FDA) approval for use of MultiHance(R) (gadobenate dimeglumine) injection in magnetic resonance imaging of the central nervous system in pediatric patients younger than two years of age
Biopharmaceuticals Devices Diagnostics Radiology FDA
 HSMN NewsFeed - 29 Jan 2018
Meso Scale Diagnostics Receives First FDA Clearance for IVD Assay
Diagnostics Personalized Medicine FDA
 HSMN NewsFeed - 29 Jan 2018
gammaCore(R) Receives FDA Clearance for the Acute Treatment of Pain Associated with Migraine Headache in Adult Patients
Devices Neurology FDA
 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 - 29 Jan 2018
MedyMatch Receives Expedited Access Pathway / Breakthrough Device Designation from the FDA to Accelerate Market Access for Intracranial Hemorrhage Software
Devices Radiology Neurosurgery FDA
 HSMN NewsFeed - 29 Jan 2018
SyntheticMR AB - Segmentation and Quantification of Brain Tissue, and Industry First Myelin Volume Measurements in SyMRI now FDA Cleared
Devices Radiology Neurology FDA
 HSMN NewsFeed - 25 Jan 2018
Aptima(R) HBV Quant Assay for Quantitation of Hepatitis B Viral Load Receives PMA Approval
Diagnostics FDA
 HSMN NewsFeed - 24 Jan 2018
Perrigo Announces Final FDA Approval Of A Generic Version Of Estrace(R) Cream
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 24 Jan 2018
Perrigo Announces Final FDA Approval And Launch Of An AB Rated Generic Version Of Epiduo(R) Gel
Biopharmaceuticals Generics FDA Product Launch
 HSMN NewsFeed - 23 Jan 2018
TECHLAB Receives FDA 510(k) Clearance To Market CAMPYLOBACTER QUIK CHEK(TM) and CAMPYLOBACTER CHEK(TM) Tests
Diagnostics Gastroenterology Product Launch
 HSMN NewsFeed - 22 Jan 2018
Elanco Animal Health Announces U.S. Food and Drug Administration (FDA) Approval of Credelio(R) (lotilaner) to Treat and Protect Against Ticks and Fleas
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 - 17 Jan 2018
Avion Pharmaceuticals announces approval of first NDA in the oral contraceptive category
Biopharmaceuticals FDA
 HSMN NewsFeed - 17 Jan 2018
International Biophysics obtains FDA 510k clearance for the FloPump(R) 32 centrifugal heart pump
Devices Cardiology FDA
 HSMN NewsFeed - 17 Jan 2018
Novartis granted US FDA Priority Review for Kymriah(TM) (tisagenlecleucel), formerly CTL019, for adults with r/r DLBCL
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 17 Jan 2018
Pharming Announces FDA Acceptance for Review of Supplemental Biologics License Application for RUCONEST(R) for Prophylaxis of Hereditary Angioedema Attacks
Biopharmaceuticals FDA
 HSMN NewsFeed - 16 Jan 2018
Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps FDA is taking to enhance transparency of clinical trial information to support innovation and scientific inquiry related to new drugs
Biopharmaceuticals FDA
 HSMN NewsFeed - 12 Jan 2018
Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA decision to seek additional time to reassess rule that would have changed longstanding practices for how the agency determined the 'intended use' of medical products
Devices FDA
 HSMN NewsFeed - 12 Jan 2018
GSK receives FDA approval for expanded indication for FLUARIX(R) QUADRIVALENT (Influenza Vaccine) for persons 6 months and older
Biopharmaceuticals FDA
 HSMN NewsFeed - 12 Jan 2018
BD Statement on FDA Warning Letter for Preanalytical Systems Business Unit
Devices FDA
 HSMN NewsFeed - 12 Jan 2018
FDA warns Becton Dickinson & Company of significant violations of the law as part of ongoing investigation into lead testing issues
Devices FDA
 HSMN NewsFeed - 11 Jan 2018
Resverlogix Receives FDA Protocol Acceptance for the Ongoing Phase 3 BETonMACE Trial
Biopharmaceuticals Cardiology FDA
 HSMN NewsFeed - 11 Jan 2018
Boston Scientific Receives U.S. FDA Approval for Spectra WaveWriter(TM) Spinal Cord Stimulator System
Devices Neurology FDA
 HSMN NewsFeed - 10 Jan 2018
Morphotek Announces FDA Acceptance Of Investigational New Drug Application For Next-Generation Farletuzumab Antibody-Drug Conjugate MORAb-202
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 9 Jan 2018
Xcision Receives FDA 510(k) Clearance for the GammaPod Stereotactic Radiotherapy System for Breast Cancer
Devices Oncology FDA
 HSMN NewsFeed - 8 Jan 2018
Clearbridge BioMedics' ClearCell(R) FX1 system achieves U.S. FDA listing
Devices Diagnostics Oncology FDA
 HSMN NewsFeed - 8 Jan 2018
Varian Halcyon Treatment System Receives Taiwan FDA Approval
Devices Oncology Regulatory
 HSMN NewsFeed - 8 Jan 2018
Nevro Receives FDA Approval for Senza II(TM) Spinal Cord Stimulation System Delivering HF10(TM) Therapy
Devices FDA
 HSMN NewsFeed - 5 Jan 2018
FDA Approves XGEVA(R) (denosumab) For The Prevention Of Skeletal-Related Events In Patients With Multiple Myeloma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 4 Jan 2018
NuVasive Extends First-Of-Its-Kind Porous PEEK Interbody To TLIF And PLIF Procedures
Devices Orthopaedic Neurosurgery FDA Product Launch
 HSMN NewsFeed - 4 Jan 2018
Novartis drug Promacta(R) receives FDA Breakthrough Therapy designation for first-line use in severe aplastic anemia (SAA)
Biopharmaceuticals 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 - 3 Jan 2018
New FDA MR-Conditional Labeling Approvals Further Expand Abbott's Portfolio of MRI-Ready Devices
Devices Cardiology Radiology FDA
 HSMN NewsFeed - 3 Jan 2018
Inova Diagnostics Receives FDA Clearance for the First Fully Automated, Random Access Calprotectin Test
Diagnostics FDA
 HSMN NewsFeed - 3 Jan 2018
Perrigo Announces Tentative FDA Approval For The Generic Version Of Prolensa(R) Ophthalmic Solution 0.07%
Biopharmaceuticals Generics Ophthalmology 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 - 29 Dec 2017
Mylan Adds to U.S. Women's Healthcare Portfolio With FDA Approval of First Generic for Estrace(R) Cream
Biopharmaceuticals Generics FDA Product Launch
 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 - 26 Dec 2017
FDA Grants INSYS Therapeutics ‘Fast Track’ Designation for Cannabidiol (CBD) Oral Solution as Investigational Treatment for Prader-Willi Syndrome
Biopharmaceuticals FDA
 HSMN NewsFeed - 26 Dec 2017
Organovo Receives Orphan Designation From U.S. FDA for 3D Bioprinted Therapeutic Liver Tissue Treatment of Alpha-1 Antitrypsin Deficiency
Regenerative Medicine FDA
 HSMN NewsFeed - 22 Dec 2017
FDA clears stereotactic radiotherapy system for use in treating breast cancer
Devices Oncology FDA
 HSMN NewsFeed - 22 Dec 2017
Novartis' combination therapy Tafinlar(R) + Mekinist(R) granted FDA Priority Review for the adjuvant treatment of stage III BRAF V600 mutation-positive melanoma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 21 Dec 2017
Jazz Pharmaceuticals Submits New Drug Application for Solriamfetol (JZP-110) for Excessive Sleepiness Associated with Narcolepsy and Obstructive Sleep Apnea
Biopharmaceuticals FDA
 HSMN NewsFeed - 21 Dec 2017
Santen Receives Complete Response Letter from U.S. FDA for Intravitreal Sirolimus (DE-109)
Biopharmaceuticals Ophthalmology FDA
 HSMN NewsFeed - 20 Dec 2017
PENTAX Medical Announces Launch Of First FDA-Cleared HD Duodenoscope With Disposable Distal Cap
Devices Gastroenterology FDA Product Launch
 HSMN NewsFeed - 19 Dec 2017
Prescient Surgical Receives FDA 510(k) Clearance for Its Novel CleanCision(TM) Wound Retraction and Protection System
Devices Surgery FDA
 HSMN NewsFeed - 18 Dec 2017
Novartis multiple sclerosis therapy fingolimod granted FDA Breakthrough Therapy designation for pediatric MS
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 18 Dec 2017
FDA Approves Ortho Clinical Diagnostics VITROS(R) Immunodiagnostic Products HIV Combo Reagent Pack and Calibrator on the VITROS(R) 3600 Immunodiagnostic System
Diagnostics HIV/AIDS FDA
 HSMN NewsFeed - 15 Dec 2017
Egalet Receives FDA Tentative Approval for Expanded Label for ARYMO(R) ER (morphine sulfate) C-II, an Extended-Release Morphine Product Formulated with Abuse-Deterrent Properties for Treatment of Chronic Pain
Biopharmaceuticals FDA
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