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

Aug 15, 2016, 08:30 ET EDWARDS INTUITY Elite Rapid Deployment Valve Receives FDA Approval

 Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care...


Aug 15, 2016, 08:00 ET WuXi AppTec's STA Subsidiary Passed Third U.S. FDA Inspection

WuXi AppTec Co. Ltd. (WuXi), a leading open-access R&D capability and technology platform company serving the pharmaceutical, biotechnology,...


Aug 10, 2016, 01:00 ET Kitov Announces Issuance of U.S. Patent Securing Long-Term Exclusivity for KIT-302 Ahead of New Drug Application to the FDA

Kitov Pharmaceuticals (NASDAQ/TASE: KTOV), an innovative biopharmaceutical company focused on late-stage drug development, today announced that...


Aug 09, 2016, 15:44 ET Magellan Diagnostics Receives CFDA Clearance for LeadCare II in China

 Magellan Diagnostics, a business unit of Meridian Bioscience (NASDAQ: VIVO), has received clearance from the China Food and Drug...


Aug 09, 2016, 09:03 ET BONESUPPORT™ Receives FDA Approval to Initiate IDE Clinical Study

FORTIFY Study to Assess CERAMENT G as Part of Surgical Repair of OpenDiaphyseal Tibial Fractures   BONESUPPORT AB, an emerging leader in...


Aug 09, 2016, 09:00 ET The First US Study With FDA Cleared Point-of-Care Device to Help Physicians in Diagnosing Osteoporosis was Published in a Respected International Journal

The internationally respected journal Osteoporosis International has published the results of a US validation study* involving the world's first...


Aug 09, 2016, 07:00 ET Boston Scientific Announces U.S. FDA Approval Of EMBLEM™ MRI S-ICD System

 Boston Scientific (NYSE: BSX) has received U.S. Food and Drug Administration (FDA) approval for the EMBLEM™ MRI Subcutaneous Implantable...


Aug 08, 2016, 12:00 ET FDA Approves the Next Generation ActiveCare®

Medical Compression Systems (MCS), announced today that it has obtained US Food and Drug Administration (FDA) clearance for its new comprehensive...


Aug 08, 2016, 08:30 ET Luminex Corporation Receives FDA Emergency Use Authorization for Zika Virus Molecular Detection Assay

 Luminex Corporation (NASDAQ: LMNX) today announced that it has received Emergency Use Authorization (EUA) from the U.S. Food and Drug...


Aug 05, 2016, 10:52 ET Hematogenix Laboratory Services, LLC (Hematogenix) Continues to Expand Their Comprehensive Test Offering in Immuno-Oncology with the Addition of the VENTANA PD-L1 (SP142) and (SP263) Assays

Hematogenix®, an industry leader in the field of integrated pathology services for drug development and immuno-oncology testing, announces the...


Aug 05, 2016, 10:39 ET FDA Publishes Final Finding of No Significant Impact and Environmental Assessment on Oxitec's Self-limiting Mosquito

 The US Food and Drug Administration's Center for Veterinary Medicine (FDA-CVM) today published a final finding of no significant impact...


Aug 03, 2016, 16:11 ET EndoChoice Receives FDA Clearance for Lumos™ with Adaptive Matrix Imaging

 EndoChoice Holdings, Inc. (NYSE: GI) announced the recent FDA clearance and US launch of Lumos™ with Adaptive Matrix Imaging. This...


Aug 03, 2016, 15:37 ET Multimedia Assets Now Available: Ipsen Biopharmaceuticals, Inc. announces FDA approval of Dysport® (abobotulinumtoxinA) for the treatment of lower limb spasticity in pediatric patients aged two and older

 Ipsen Biopharmaceuticals, Inc., a subsidiary of Ipsen SA (Euronext: IPN; ADR: IPSEY) (Ipsen), today announced that the U.S. Food and Drug...


Aug 03, 2016, 08:30 ET Luminex Corporation Receives FDA Clearance for New Molecular Test for Identification and Differentiation of Influenza A/B and Respiratory Syncytial Virus

 Luminex Corporation (NASDAQ: LMNX) today announced that it has received FDA clearance for the ARIES® Flu A/B & RSV Assay. This...


Aug 03, 2016, 08:03 ET FDA Approves FLONASE® Sensimist™ Allergy Relief

 GSK Consumer Healthcare announced today that the U.S. Food and Drug Administration (FDA) has approved FLONASE® Sensimist™ Allergy...


Aug 03, 2016, 07:00 ET Novartis CDK4/6 inhibitor LEE011 (ribociclib) receives FDA Breakthrough Therapy designation as first-line treatment for HR+/HER2- advanced breast cancer

 Novartis announced today that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to LEE011 (ribociclib),...


Aug 02, 2016, 11:34 ET FDA expands use of PeriCoach at-home pelvic floor trainer device and smartphone app for sexual health

 Analytica announced that the U.S. Food and Drug Administration (FDA) clarified use for PeriCoach to potentially improve sexual sensation or...


Aug 02, 2016, 09:37 ET AMERIGEN announces final approval from FDA for generic version of Lysteda®

 Amerigen Pharmaceuticals Limited ("Amerigen") today announced that the U.S. Food and Drug Administration (FDA) has granted final approval to...


Aug 02, 2016, 09:00 ET VM BioPharma Announces Korea Food and Drug Administration Approval of Phase 2 Clinical Trial for Investigational Gene Therapy VM202 in Ischemic Heart Disease

 VM BioPharma, the US division of ViroMed Co., Ltd. in Seoul, South Korea (KOSDAQ: 084990), announced today that the company has obtained...


Aug 01, 2016, 09:57 ET Getting a Leg Up on Body Shaping: BTL Aesthetics Announces FDA Clearance for Thighs

 BTL Aesthetics today announced that it has received a new designation from the Food & Drug Administration (FDA) for its award-winning,...


Aug 01, 2016, 08:59 ET Essential Medical Inc. Announces FDA Approval to Begin a U.S. Clinical Trial for the X-Seal 6F Vascular Closure Device

Essential Medical, Inc., a privately held medical device company addressing the vascular closure market, announced today that it has received...


Aug 01, 2016, 08:30 ET MEI Pharma's Pracinostat Receives Breakthrough Therapy Designation from FDA for Treatment in Combination with Azacitidine of Patients with Newly Diagnosed Acute Myeloid Leukemia Unfit for Intensive Chemotherapy

 MEI Pharma, Inc. (Nasdaq: MEIP), an oncology company focused on the clinical development of novel therapies for cancer, announced today that...


Aug 01, 2016, 08:00 ET Ipsen Biopharmaceuticals, Inc. announces FDA approval of Dysport® (abobotulinumtoxinA) for the treatment of lower limb spasticity in pediatric patients aged two and older

 Ipsen Biopharmaceuticals, Inc., a subsidiary of Ipsen SA (Euronext: IPN; ADR: IPSEY) (Ipsen), today announced that the U.S. Food and Drug...


Aug 01, 2016, 07:00 ET HETLIOZ® is Now Available for the Treatment of Non-24-Hour Sleep-Wake Disorder in Germany

 Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA) today announced that HETLIOZ® (tasimelteon) is now available for the treatment of...


Aug 01, 2016, 07:00 ET Shire Announces FDA Approval of adynovate with BAXJECT III Reconstitution System

Shire plc (LSE: SHP, NASDAQ: SHPG) announced that the U.S. Food and Drug Administration (FDA) has approved the BAXJECT III reconstitution system...