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

Healthcare News Roundup: FDA

HSMN NewsFeed - 2 Jul 2015
Galderma Receives FDA Approval to Market Restylane(R) Lyft with Lidocaine to Correct Age Related Volume Loss in the Cheek Area
Biopharmaceuticals Dermatology FDA

HSMN NewsFeed - 1 Jul 2015
MX Orthopedics Receives FDA Clearance on the dynaMX(TM) Compression Staple Featuring Malleable Nitinol Technology
Devices Orthopaedic FDA

HSMN NewsFeed - 26 Jun 2015
Caldera Medical Announces FDA Clearance for New Generation of Vertessa(R) Lite Polypropylene Mesh for Sacrocolpopexy
Devices Product Launch FDA

HSMN NewsFeed - 24 Jun 2015
Medical Device Firm Advanced Cooling Therapy Receives FDA De Novo Clearance for Esophageal Cooling Device to Cool and Warm Patients
Devices FDA

HSMN NewsFeed - 22 Jun 2015
Vaxil's Lead Product ImMucin has Been Granted an Orphan Drug Designation by the FDA for the Treatment of Multiple Myeloma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 16 Jun 2015
Cerapedics Announces FDA Advisory Committee Panel Is Not Required for i-FACTOR(TM) PMA Approval
Devices Orthopaedic FDA

HSMN NewsFeed - 15 Jun 2015
FH Ortho Receives FDA 510(k) Clearance for Its CALCAnail(R) Orthopedic Arthrodesis Nail
Devices Orthopaedic FDA

HSMN NewsFeed - 12 Jun 2015
FDA Approves Promacta(R) for New Pediatric Chronic Immune Thrombocytopenia (cITP) Indication
Biopharmaceuticals FDA

HSMN NewsFeed - 9 Jun 2015
Cohera Medical, Inc.(R) Receives Expedited Access Pathway Designation from FDA for Sylys(R) Surgical Sealant
Devices Surgery FDA

HSMN NewsFeed - 1 Jun 2015
TransEnterix Submits 510(k) Application to FDA for SurgiBot System
Devices Surgery FDA

HSMN NewsFeed - 26 May 2015
Sunshine Heart Announces FDA Approval to Resume Enrollment in COUNTER HF(TM) US Pivotal Study for C-Pulse(R) Heart Assist System
Devices Cardiology FDA

HSMN NewsFeed - 26 May 2015
Roche receives FDA clearance for the cobas(R) Cdiff Test to detect Clostridium difficile
Diagnostics FDA

HSMN NewsFeed - 21 May 2015
Tris Pharma Announces the FDA Acceptance of NDA for Dyanavel(TM) XR
Biopharmaceuticals Drug Delivery

HSMN NewsFeed - 19 May 2015
FDA Grants Premarket Approval for Silk Road Medical's ENROUTE(R) Transcarotid Stent System
Devices Interventional FDA

HSMN NewsFeed - 14 May 2015
PENTAX Medical Reaffirms Commitment to Work with FDA and Industry Partners To Address Duodenoscope Infection Issues
Devices Gastroenterology Urology

HSMN NewsFeed - 12 May 2015
Aspyrian Therapeutics Inc. Announces FDA Acceptance of an Investigational New Drug Application for RM-1929, a First-in-Class, Precision-Targeted Therapy for Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 12 May 2015
Merck KGaA, Darmstadt, Germany, Receives FDA Fast Track Designation for Evofosfamide for the Treatment of Patients Living With Advanced Pancreatic Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 11 May 2015
FDA Grants Priority Review Status for Novocure’s PMA Supplement Application of Optune in Newly Diagnosed Glioblastoma
Devices Oncology FDA

HSMN NewsFeed - 11 May 2015
Roche Receives FDA Approval for cobas(R) KRAS Mutation Test
Diagnostics Oncology FDA

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