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 23, 2016, 09:10 ET Perrigo Announces Tentative FDA Approval For Generic Version Of Suprep® Oral Solution And Confirms Patent Challenge For Generic Version Of Mirvaso® Gel

Perrigo Company plc (NYSE: PRGO; TASE) today announced it has received tentative approval from the U.S. Food and Drug Administration ("FDA") for...


Aug 23, 2016, 09:05 ET ImPACT® Is The First Concussion-Specific Medical Device to Receive FDA Clearance

ImPACT, the most widely-used and most scientifically-validated computerized neurocognitive concussion management tool available, is the first...


Aug 23, 2016, 08:46 ET The Days of Biosimilars and Molecular Testing Are Here; Are We Ready?

 As the use of biosimilars in cancer care rapidly expands, the National Comprehensive Cancer Network® (NCCN®) will convene oncology...


Aug 22, 2016, 09:14 ET Cochlear™ Nucleus® cochlear implants now have access to 3.0T MRI

Cochlear Limited (ASX: COH), the global leader in implantable hearing solutions, announces today the U.S. Food and Drug Administration (FDA)...


Aug 22, 2016, 06:00 ET Lilly and AstraZeneca Receive FDA Fast Track Designation for AZD3293, an Investigational Treatment for Early Alzheimer's Disease

Eli Lilly and Company (NYSE: LLY) and AstraZeneca today announced they have received U.S. Food and Drug Administration (FDA) Fast Track designation...


Aug 19, 2016, 04:07 ET Chinese FDA Grants MammaTyper Innovative Product Status for Expedited Approval

BioNTech Diagnostics GmbH, a fully owned subsidiary of BioNTech AG, and its Chinese partner Shuwen Biotech Co. Ltd. today announced that the...


Aug 18, 2016, 14:59 ET Edwards SAPIEN 3 Transcatheter Heart Valve Receives Expanded Indication From FDA

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


Aug 18, 2016, 14:39 ET FDA approves expanded indication for two transcatheter heart valves for patients at intermediate risk for death or complications associated with open-heart surgery

The U.S. Food and Drug Administration today approved an expanded indication for the Sapien XT and Sapien 3 transcatheter heart valves for patients...


Aug 18, 2016, 10:53 ET AMERIGEN announces final approval from FDA for generic version of Temodar®

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


Aug 18, 2016, 09:00 ET Following Successful First Stage in Trial: Kadimastem Signed Agreement with Medical Device Company to Expand Joint Trials of Diabetes Therapy using Unique Encapsulation Device

Israeli biotechnology company Kadimastem (TASE: KDST) announced today that following success in the first stage of trials held under the agreement...


Aug 18, 2016, 07:00 ET FDA Grants Soligenix Orphan Drug Designation for Dusquetide for Treatment of Macrophage Activation Syndrome

 Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing...


Aug 17, 2016, 13:23 ET Pulmatrix Receives Orphan Drug Designation from the FDA for Inhaled Drug to Treat Pulmonary Fungal Infections in Cystic Fibrosis Patients

Pulmatrix, Inc. (NASDAQ: PULM) announced today that the U.S. Food & Drug Administration has granted the company's request for orphan drug...


Aug 16, 2016, 14:36 ET Seqirus announces shipment of FLUAD™ (Influenza Vaccine, Adjuvanted) in the US for 2016-2017 flu season

 Seqirus has begun shipping FLUAD™ (Influenza Vaccine, Adjuvanted) for the 2016-2017 flu season since gaining approval from the Food and...


Aug 15, 2016, 16:30 ET Aratana Therapeutics Granted FDA Approval of NOCITA® (bupivacaine liposome injectable suspension)

Aratana Therapeutics, Inc. (NASDAQ: PETX), a pet therapeutics company focused on the licensing, development and commercialization of innovative...


Aug 15, 2016, 12:41 ET Spinal Simplicity Introduces Innovative Implant With Hydroxyapatite Coating

 Spinal Simplicity, a medical device company based in Overland Park, Kan., that develops innovative solutions to treat complex surgical...


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...