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

Healthcare News Roundup: FDA

HSMN NewsFeed - 27 Feb 2019
eNeura, Inc. Receives FDA Clearance for Acute Treatment and Prevention of Migraine in Children 12 Years of Age and Older
Devices Neurology FDA

HSMN NewsFeed - 25 Feb 2019
FDA Approves Taiho Oncology's LONSURF(R) (trifluridine/tipiracil) for Adult Patients with Previously Treated Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 21 Feb 2019
Agfa Receives FDA 510(k) Clearance for DR 800 With Tomosynthesis
Devices Radiology FDA

HSMN NewsFeed - 21 Feb 2019
ViewRay Announces FDA 510(k) Clearance for Advancements in MRI and Functional Imaging Technologies for MRIdian MRI-Guided Radiation Therapy System
Devices Oncology Radiology FDA

HSMN NewsFeed - 20 Feb 2019
HemoCue Announces FDA 510(k) Clearance and U.S. Launch of Its Latest Point-of-Care Hemoglobin Test, the HemoCue(R) Hb 801 System
Diagnostics FDA Product Launch

HSMN NewsFeed - 20 Feb 2019
MagVenture, Inc.: Robotic Aid to Drugfree Depression Treatment Receives FDA Clearance
Devices Neurology FDA

HSMN NewsFeed - 20 Feb 2019
Hygieia Receives 510(k) Clearance from FDA for Phone App That Enhances Company's d-Nav Insulin Guidance Service
Devices Endocrinology FDA

HSMN NewsFeed - 19 Feb 2019
AbbVie Announces New Drug Application Accepted for Priority Review by U.S. FDA for Upadacitinib for Treatment of Moderate to Severe Rheumatoid Arthritis
Biopharmaceuticals FDA

HSMN NewsFeed - 19 Feb 2019
ReWalk Announces 510k FDA Submission for ReStore(TM) Exo-Suit for Stroke Rehabilitation
Devices FDA

HSMN NewsFeed - 14 Feb 2019
Lipocine Inc. Announces FDA Clearance of IND to Commence Phase 2 Study of LPCN 1144 in Biopsy Confirmed NASH Subjects
Biopharmaceuticals FDA

HSMN NewsFeed - 12 Feb 2019
U.S. FDA Approves DARZALEX(R) (daratumumab) Split-Dosing Regimen
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 11 Feb 2019
BioDirection Receives Breakthrough Device Designation from FDA for Tbit(TM) System
Devices Diagnostics Neurology FDA

HSMN NewsFeed - 11 Feb 2019
FDA Grants Orphan Drug Designation to Amplyx Pharmaceuticals for APX001 for Treatment of Cryptococcosis
Biopharmaceuticals FDA

HSMN NewsFeed - 4 Feb 2019
BioLineRx Receives Orphan Drug Designation From the FDA for its Lead Therapeutic Candidate BL-8040 for the Treatment of Pancreatic Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 28 Jan 2019
U.S. FDA Approves IMBRUVICA(R) (ibrutinib) Plus Obinutuzumab as First Non-Chemotherapy Combination Regimen for Treatment-Naïve Patients with Chronic Lymphocytic Leukemia
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 25 Jan 2019
Zimmer Biomet Receives FDA Clearance for ROSA(R) Knee System for Robotically-Assisted Surgeries
Devices Orthopaedic FDA

HSMN NewsFeed - 16 Jan 2019
Therachon is Granted Orphan Drug Designation by US FDA for Apraglutide for the Treatment of Short Bowel Syndrome
Biopharmaceuticals Gastroenterology FDA

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