Healthcare Sales & Marketing Network: FDA News Roundup

Healthcare News Roundup: 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 - 7 Dec 2018
Contego Medical Receives 510(k) Clearance for the Vanguard IEP Peripheral Angioplasty System with Integrated Embolic Protection
Devices Interventional 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 - 15 Nov 2018
New Approvals Allow Chronic Pain Sufferers to Try Abbott's Non-Opioid Pain Therapy Before Getting Device Implant
Devices Neurology FDA Regulatory 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

HSMN NewsFeed - 9 Nov 2018
FDA authorizes emergency use of first Ebola fingerstick test with portable reader
Diagnostics FDA

HSMN NewsFeed - 7 Nov 2018
HemoScreen(TM) Hematology Analyzer for Point of Care, Receives FDA 510(k) Clearance
Devices Diagnostics FDA

HSMN NewsFeed - 6 Nov 2018
FDA Approves Ortho Clinical Diagnostics VITROS(R) Immunodiagnostic Products HIV Combo Reagent Pack and Calibrator for use on the VITROS(R) 5600 Integrated System
Diagnostics HIV/AIDS FDA

HSMN NewsFeed - 6 Nov 2018
Lannett Announces Expanded Agreement With Strategic Alliance Partner, HEC Pharm Group, To Distribute Two FDA-Approved Products
Biopharmaceuticals Licensing Distribution

HSMN NewsFeed - 5 Nov 2018
Galderma Announces FDA Approval of Restylane(R) Lyft For Midface Injection via Cannula
Devices Dermatology FDA

HSMN NewsFeed - 5 Nov 2018
Shoulder Innovations Announces FDA 510(k) Clearance For Shoulder Technology
Devices Orthopaedic FDA

HSMN NewsFeed - 2 Nov 2018
Aquestive Therapeutics Announces U.S. Food and Drug Administration (FDA) Approval for SYMPAZAN(TM) (clobazam) Oral Film
Biopharmaceuticals Drug Delivery FDA

HSMN NewsFeed - 1 Nov 2018
FDA's Center for Devices and Radiological Health and Center for Drug Evaluation and Research on agency's warning to consumers about genetic tests that claim to predict patients' responses to specific medications
Biopharmaceuticals Diagnostics FDA

HSMN NewsFeed - 1 Nov 2018
OsteoRemedies(R) Announces the First FDA Cleared Dual-Antibiotic Spacer and Bone Cement with Gentamicin and Vancomycin
Devices Orthopaedic FDA Product Launch

HSMN NewsFeed - 1 Nov 2018
Senhwa Biosciences Silmitasertib filed IND of Basal Cell Carcinoma approved by FDA
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 31 Oct 2018
Egalet Signs Asset Purchase Agreement to Acquire Four FDA-Approved, Non-Narcotic Pain Products
Biopharmaceuticals Acquisitions

HSMN NewsFeed - 30 Oct 2018
U.S. FDA Approves INVOKANA(R) (canagliflozin) to Reduce the Risk of Heart Attack, Stroke or Cardiovascular Death in Adults with Type 2 Diabetes and Established Cardiovascular Disease
Biopharmaceuticals Endocrinology Cardiology FDA

HSMN NewsFeed - 26 Oct 2018
Mayne Pharma Acquires FDA-approved halobetasol foam, Complementing US Dermatology Portfolio
Biopharmaceuticals Dermatology Acquisitions

HSMN NewsFeed - 25 Oct 2018
Abbott Introduces the Next Generation of Influenza A & B and Strep A Assays with Fastest-Ever Time to Molecular Results
Diagnostics FDA Product Launch

HSMN NewsFeed - 24 Oct 2018
FDA Approves New SynchroMed(TM) II myPTM(TM) Personal Therapy Manager That Enables Patients to Alleviate Unpredictable Pain
Devices Drug Delivery Neurology FDA

HSMN NewsFeed - 24 Oct 2018
Inova Diagnostics Launches First FDA Cleared Calprotectin Extraction Device
Devices Diagnostics FDA Product Launch

HSMN NewsFeed - 24 Oct 2018
Anixa Biosciences Announces Scheduling of Pre-Sub Meeting with FDA for its Cchek(TM) Cancer Diagnostic Test
Diagnostics Oncology FDA

HSMN NewsFeed - 23 Oct 2018
Monteris(R) Medical Announces FDA Clearance of Laser Probe with Fiber Optic Controlled Cooling for Use with the NeuroBlate(R) System
Devices Neurosurgery FDA

HSMN NewsFeed - 23 Oct 2018
COMPASS Pathways Receives FDA Breakthrough Therapy Designation for Psilocybin Therapy for Treatment-resistant Depression
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 23 Oct 2018
Duchesnay Inc. Announces Submission of Supplemental New Drug Application (sNDA) for Osphena(R) (ospemifene) to U.S. FDA Seeking Approval for the Treatment of Vaginal Dryness, a Symptom of Vulvar and Vaginal Atrophy (VVA) Due to Menopause
Biopharmaceuticals FDA

HSMN NewsFeed - 22 Oct 2018
Eiger BioPharmaceuticals Receives FDA Rare Pediatric Disease (RPD) Designation for Lonafarnib for the Treatment of Progeria and Progeroid Laminopathies and Plans NDA Filing in 2019
Biopharmaceuticals FDA

HSMN NewsFeed - 22 Oct 2018
FDA Approves Asthma Indication for Dupixent(R) (dupilumab)
Biopharmaceuticals FDA

HSMN NewsFeed - 19 Oct 2018
Abbott's HeartMate 3 Heart Pump Now FDA Approved for Advanced Heart Failure Patients Not Eligible for a Heart Transplant
Devices Cardiology FDA

HSMN NewsFeed - 17 Oct 2018
AbbVie Announces Supplemental New Drug Application Accepted for Priority Review by U.S. FDA for IMBRUVICA(R) (ibrutinib) in Combination with Obinutuzumab (GAZYVA(R)) for Previously Untreated Chronic Lymphocytic Leukemia (CLL)
Biopharmaceuticals Oncology FDA

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