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The Healthcare Sales & Marketing Network celebrates 28 years serving the medical sales & marketing community.Connecting Medical Sales Reps with MedTech/BioPharma Recruiters and Independent Reps with and New Product LinesConnecting Medical Sales Reps with MedTech/BioPharma Recruiters and Independent Reps with and New Product Lines

Healthcare News Roundup: FDA

 HSMN NewsFeed - 2 Jan 2019
Slayback Pharma Announces FDA Approval of Hydroxyprogesterone Caproate Injection, USP 1,250 mg/ 5 ml in a Multi-Dose Vial, the First Generic Equivalent of Makena(R) Injection 1,250 mg/ 5 ml Multi-Dose Vial
Biopharmaceuticals Generics FDA Product Launch
 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 - 28 Dec 2018
Edwards' SAPIEN 3 Ultra Transcatheter Heart Valve Receives FDA Approval
Devices Interventional Cardiology 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 - 19 Dec 2018
Eiger Announces Breakthrough Therapy Designation Granted by FDA for Lonafarnib in Progeria and Progeroid Laminopathies
Biopharmaceuticals FDA
 HSMN NewsFeed - 13 Dec 2018
FDA Grants Fast Track Designation to the Baricitinib Development Program for the Treatment of Systemic Lupus Erythematosus (SLE)
Biopharmaceuticals FDA
 HSMN NewsFeed - 10 Dec 2018
Merck KGaA, Darmstadt, Germany Announces FDA Orphan Drug Designation for Bifunctional Immunotherapy M7824 in Biliary Tract Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 5 Dec 2018
Olympus Spiration(R) Valve System Is FDA Approved for the Endobronchial Treatment of Emphysema
Devices FDA
 HSMN NewsFeed - 5 Dec 2018
Bausch & Lomb Receives 510(K) Clearance From FDA For Bausch & Lomb Ultra(R) Multifocal For Astigmatism Contact Lenses
Devices Ophthalmology FDA
 HSMN NewsFeed - 5 Dec 2018
Subtle Medical Receives FDA 510(k) Clearance and CE Mark Approval for SubtlePET(TM)
Devices Radiology FDA Regulatory
 HSMN NewsFeed - 29 Nov 2018
FDA Accepts Filing of New Estrogen-free Oral Contraceptive Developed by Exeltis
Biopharmaceuticals FDA
 HSMN NewsFeed - 28 Nov 2018
FDA Approves Expanded Use for Ortho Clinical Diagnostics VITROS(R) HIV Combo Test
Devices Diagnostics HIV/AIDS FDA
 HSMN NewsFeed - 27 Nov 2018
Mesa Biotech Receives FDA 510(k) Clearance and CLIA Waiver for Its Accula(TM) RSV Molecular Point of Care Test
Diagnostics FDA
 HSMN NewsFeed - 26 Nov 2018
Perrigo Announces Tentative FDA Approval For The First To File Generic Version Of Ultravate(R) Lotion 0.05%
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 26 Nov 2018
Biohaven Announces FDA Acceptance of 505(b)(2) NDA Filing for BHV-0223, a Novel Sublingual Delivery Form of Riluzole for the Treatment of Amyotrophic Lateral Sclerosis (ALS)
Biopharmaceuticals Neurology Drug Delivery FDA
 HSMN NewsFeed - 21 Nov 2018
FDA Closes Inquiry Regarding IHCTOA Letter Regarding Sciton's diVa(R) Laser
Devices Dermatology FDA
 HSMN NewsFeed - 21 Nov 2018
OBI Pharma Granted FDA Orphan Drug Designation for OBI-888 for the Treatment of Pancreatic Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 20 Nov 2018
FDA Approves Gamifant(R) (emapalumab), the First and Only Treatment for Primary Haemophagocytic Lymphohistiocytosis (HLH)
Biopharmaceuticals FDA
 HSMN NewsFeed - 20 Nov 2018
OrthoXel(TM) Orthopaedic Trauma Device Company Announce CE Mark Clearance Following FDA 510(k) for new Apex Femoral Nailing System
Devices Orthopaedic Regulatory
 HSMN NewsFeed - 20 Nov 2018
Pliant Therapeutics Receives FDA Orphan Drug Designation for Lead Program PLN-74809 in Primary Sclerosing Cholangitis
Biopharmaceuticals FDA
 HSMN NewsFeed - 19 Nov 2018
FDA Approves AEMCOLO(TM) (rifamycin), the First Antibiotic Approved for the Treatment of Travelers' Diarrhea in Over a Decade
Biopharmaceuticals FDA Product Launch
 HSMN NewsFeed - 14 Nov 2018
Lilly Submits New Drug Application to the FDA for Lasmiditan for Acute Treatment of Migraine, Receives Breakthrough Therapy Designation for Emgality(TM) (galcanezumab-gnlm) for Prevention of Episodic Cluster Headache
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 13 Nov 2018
STERIBITE(R) Announces FDA Clearance of the Steribite Disposable Kerrison Rongeur
Devices Orthopaedic Neurosurgery FDA
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