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Healthcare News Roundup: 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
 HSMN NewsFeed - 16 Oct 2018
FDA Approves Medicines360's sNDA for LILETTA(R) (levonorgestrel-releasing intrauterine system) 52 mg to Prevent Pregnancy for up to Five Years
Biopharmaceuticals Drug Delivery FDA
 HSMN NewsFeed - 15 Oct 2018
CIVCO Radiotherapy Announces FDA 510k Clearance and CE Mark of their Solstice SRS Immobilization System
Devices Oncology FDA Regulatory
 HSMN NewsFeed - 12 Oct 2018
FDA Approves Grifols ID CORE XT Test For Molecular Red Blood Cell Typing
Diagnostics FDA
 HSMN NewsFeed - 12 Oct 2018
Rockwell Medical Provides Update on IV Triferic
Biopharmaceuticals FDA
 HSMN NewsFeed - 11 Oct 2018
Transseptal Solutions Announces FDA Clearance of Its Novel Transseptal Access System for Transseptal Puncture and Left Atrial Navigation
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 11 Oct 2018
FDA Approves Stiolto(R) Respimat(R) Supplemental New Drug Application (sNDA) to Add Data on COPD Exacerbation Reduction
Biopharmaceuticals Drug Delivery FDA
 HSMN NewsFeed - 10 Oct 2018
SpineEX(R) Announces FDA Clearance of Sagittae(R) Lateral Lumbar Interbody Fusion Devices
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 9 Oct 2018
Lixte Biotechnology Files an IND with the FDA to Conduct a Phase 1b/2 Trial of LB-100 in Patients with Myelodysplastic Syndrome at Moffitt Cancer Center
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 8 Oct 2018
Bausch Health's BRYHALI(TM) (halobetasol propionate) Lotion, 0.01%, Receives Tentative FDA Approval For Plaque Psoriasis In Adults
Biopharmaceuticals Dermatology 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 - 5 Oct 2018
ZEISS Receives FDA Approval for ReLEx SMILE, Expanding Myopia Treatment to Patients with Astigmatism
Devices Ophthalmology FDA
 HSMN NewsFeed - 4 Oct 2018
Allergan Receives FDA Clearance To Treat Area Below The Jawline With CoolSculpting(R)
Devices Dermatology FDA
 HSMN NewsFeed - 2 Oct 2018
Processa Pharmaceuticals Receives FDA Clearance Of IND To Begin Phase 2 Clinical Development Of PCS-499 In Necrobiosis Lipoidica Patients
Biopharmaceuticals FDA
 HSMN NewsFeed - 1 Oct 2018
Perrigo Confirms Patent Challenge for Generic Version of Jublia(R) Topical Solution 10%
Biopharmaceuticals Generics FDA Litigation
 HSMN NewsFeed - 1 Oct 2018
FDA Approves KYPROLIS(R) (carfilzomib) Once-Weekly 70 mg/m2 In Combination With Dexamethasone (Kd70) For Patients With Relapsed Or Refractory Multiple Myeloma
Biopharmaceuticals Oncology FDA
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