FDA Approval The latest news regarding FDA applications, processes and approval. This section contains releases regarding the Food and Drug Administration’s consideration of new products, drugs, therapies and treatments. Find announcements covering every stage of the FDA application process, from filing to eventual approval, including appeals, resubmissions and safety alerts.

Latest FDA Approval

24 Oct, 2017, 13:03 BST Acutus Medical® Receives FDA Clearance for Advanced Cardiac Mapping Technology for Complex Arrhythmias

FDA clearance of the AcQMap® High Resolution Imaging and Mapping System and AcQMap® 3D Imaging and Mapping Catheter is a major milestone for Acutus...


19 Oct, 2017, 12:19 BST SafeTraces Secures $6.5 Million Series A Financing Round Led by Omidyar Network to Advance Disruptive On-Food Source Assurance Solutions

SafeTraces also received a prestigious FDA SBIR Phase II grant to advance commercialization of its rapid safety solution for fresh produce...


19 Oct, 2017, 07:00 BST Merck Brings Customers Closer to Gene Therapy Product Commercialization

- Company's Carlsbad, U.S., manufacturing facility passes FDA and EMA inspections - Underscores capabilities as commercial manufacturer of viral...


18 Oct, 2017, 13:45 BST Positive Developments From Clinical Studies and FDA Approvals Pushing Biotech Stocks to New Highs

Biotech Briefing: The Biotech Sector continues to impress and even surprise many as the SPDR S&P Biotech ETF (XBI) has surged 49 percent in...


10 Oct, 2017, 15:24 BST Respicardia's remedē® System Receives FDA Approval

Breakthrough Treatment of Moderate to Severe Central Sleep Apnea in Adult Patients Now Available Respicardia, Inc., a private medical...


10 Oct, 2017, 13:30 BST Ultragenyx and Kyowa Hakko Kirin Announce FDA Acceptance and Priority Review Designation of Burosumab's Biologics License Application

Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development of novel products for rare and ultra-rare...


06 Oct, 2017, 13:07 BST Game Ready® Receives FDA 510(k) Clearance For Med4 Elite™ Multi-Modality Recovery Device

The injury and surgery recovery technology leader, Game Ready®, announced today that the company has received 510(k) clearance from the U.S. Food...


04 Oct, 2017, 18:00 BST Transfer of Regulatory Jurisdiction for Oxitec's Self-limiting Friendly™ Aedes in the United States

FDA issues final Guidance for Industry, transferring regulatory authority to EPA Following new Guidance issued by the U.S. Food and Drug...


04 Oct, 2017, 09:00 BST CALCIVIS Closes Equity Funding to Advance its CALCIVIS Imaging System to Market

CALCIVIS, a medical devices company focused on revolutionising the management of tooth decay and enabling preventive dentistry, announces it has...


27 Sep, 2017, 23:41 BST No More Routine Finger Sticks(1) for Americans with Diabetes: Abbott′s FreeStyle® Libre Approved in the U.S.

- REVOLUTIONARY SYSTEM TO REPLACE BLOOD GLUCOSE MONITORING, ELIMINATING THE NEED FOR ROUTINE FINGER STICKS(1) AND FINGER STICK CALIBRATION -...


18 Sep, 2017, 09:17 BST Camurus Announces That FDA Grants Priority Review of NDA for Weekly and Monthly CAM2038 Buprenorphine Depots for Treatment of Opioid Use Disorder

The FDA has assigned a PDUFA target date of January 19, 2018 Camurus (NASDAQ STO: CAMX) announces that the U.S. Food and Drug Administration...


11 Sep, 2017, 06:00 BST Pharming Announces Conclusion of FDA End of Phase 2 Interactions on RUCONEST® for Prophylaxis of HAE

Pharming Group N.V. ("Pharming" or "the Company") (Euronext Amsterdam: PHARM) announced today that it has concluded its End-of-Phase 2...


31 Aug, 2017, 15:39 BST U.S. FDA Approves Chemo Group's Benznidazole to Treat Children with Chagas Disease

On August 29th, the U.S. Food and Drug Administration (FDA) approved Chemo Research's New Drug Application (NDA) for benznidazole. This is the...


25 Aug, 2017, 07:30 BST US Food and Drug Administration Grants Breakthrough Therapy Designation for Mogamulizumab for the Treatment of Mycosis Fungoides and Sézary Syndrome

Kyowa Hakko Kirin Co., Ltd. (Tokyo; 4151 President and CEO: Nobuo Hanai, "Kyowa Hakko Kirin") today announced that U.S. Food and Drug...