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

18 Apr, 2017, 08:30 ET Monitored Therapeutics, Inc. Receives FDA Clearance for First Full Home-Use Spirometer With Wireless Connection

Monitored Therapeutics, Inc. (MTI), an emerging best-in-class remote patient management company, has received FDA 510(k) clearance for its GoSpiro®...


18 Apr, 2017, 07:00 ET FDA confirms Prometic's PBI-4050 IPF clinical trial design

- FDA concurs with add-on placebo controlled phase 2/3 clinical trial for PBI-4050 in combination with nintedanib - Prometic to also...


18 Apr, 2017, 01:18 ET Novartis CAR-T cell therapy CTL019 receives FDA Breakthrough Therapy designation for treatment of adult patients with r/r DLBCL

Novartis announced today that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to CTL019, an...


17 Apr, 2017, 16:30 ET Enzyvant Receives FDA Breakthrough Therapy Designation and Regenerative Medicine Advanced Therapy Designation for Investigational Therapy RVT-802

Enzyvant, a biopharmaceutical company focused on developing innovative treatments for patients with rare diseases, today announced that the U.S....


17 Apr, 2017, 16:05 ET Rigel Submits New Drug Application to FDA for Fostamatinib in Chronic ITP

Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug...


17 Apr, 2017, 09:36 ET Dr. Bronner's Pledges $5 Million to MAPS to Make MDMA into FDA-Approved Medicine to Treat PTSD

On the eve of the Psychedelic Science 2017 conference being held in Oakland, California, from April 19-24, Dr. Bronner's, family-owned maker of the...


13 Apr, 2017, 11:34 ET Additive Orthopaedics Announces FDA Clearance of their Locking Lattice Plating System for the Global Extremities Market

Additive Orthopaedics, LLC., an early stage orthopaedic device company, today announced that is has received FDA 510(k) clearance for its 3D...


13 Apr, 2017, 08:00 ET Philips receives FDA clearance to market Philips IntelliSite Pathology Solution for primary diagnostic use in the U.S.

Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced it has received regulatory clearance (via De Novo...


13 Apr, 2017, 08:00 ET Relmada Announces FDA Fast Track Designation for d-Methadone for Adjunctive Treatment of Major Depressive Disorder

Relmada Therapeutics, Inc. (OTCQB: RLMD), a clinical-stage company developing novel therapies for the treatment of central nervous system (CNS)...


12 Apr, 2017, 16:57 ET FDA allows marketing of first whole slide imaging system for digital pathology

The U.S. Food and Drug Administration today permitted marketing of the Philips IntelliSite Pathology Solution (PIPS), the first whole slide imaging...


12 Apr, 2017, 07:30 ET United Orthopedic Corporation Receives U.S. FDA Clearance For Company's Polyethylene Knee Insert

United Orthopedic Corporation (UOC), a leading international designer, manufacturer and distributor of innovative orthopedic implants and...


11 Apr, 2017, 17:37 ET Neurocrine Announces FDA Approval of INGREZZA™ (valbenazine) Capsules as the First and Only Approved Treatment for Adults with Tardive Dyskinesia (TD) (with multimedia)

Neurocrine Biosciences, Inc. (NASDAQ: NBIX) announced today that the U.S. Food and Drug Administration (FDA) has approved INGREZZA™ (valbenazine)...


11 Apr, 2017, 17:25 ET FDA approves first drug to treat tardive dyskinesia

The U.S. Food and Drug Administration today approved Ingrezza (valbenazine) capsules to treat adults with tardive dyskinesia. This is the first...


11 Apr, 2017, 16:52 ET Neurocrine Announces FDA Approval of INGREZZA TM (valbenazine) Capsules as the First and Only Approved Treatment for Adults with Tardive Dyskinesia (TD)

Neurocrine Biosciences, Inc. (NASDAQ: NBIX) announced today that the U.S. Food and Drug Administration (FDA) has approved INGREZZATM (valbenazine)...


11 Apr, 2017, 07:00 ET Alere Achieves FDA Clearance for Alere™ Reader Platform and Alere BinaxNOW® Influenza A & B Card 2

Alere Inc. (NYSE: ALR), a global leader in rapid diagnostics, today announced that its Alere™ Reader, a diagnostic analyzer that can be used in...


11 Apr, 2017, 01:39 ET CORRECTION - APAC Biotech Pvt. Ltd: Indian FDA Approves the First Autologous Dendritic Cell-based Immuno-oncology Product, APCEDEN®

A first-of-its-kind Indian biotechnology company, APAC Biotech, was granted with a commercial license by Indian FDA (CDSCO - Central Drugs Standard...


09 Apr, 2017, 02:15 ET Intec Pharma Appoints U.S. Life Sciences Executive Jeffrey A. Meckler to its Board of Directors as Vice Chairman

Intec Pharma Ltd. (Nasdaq: NTEC), a clinical stage biopharmaceutical company focused on developing drugs based on its proprietary Accordion...


07 Apr, 2017, 15:53 ET Huevos: ¡manéjelos adecuadamente cuando celebre!

Durante muchos siglos, el huevo ha sido considerado un símbolo de nueva vida y se le ha asociado con celebraciones de primavera, como la Pascua y...


07 Apr, 2017, 14:05 ET Eggs: Handle Them Safely As You Celebrate!

The egg has been regarded as a symbol of new life and has been associated with springtime celebrations, such as Easter and Passover, for many...


07 Apr, 2017, 10:56 ET FDA approves two hepatitis C drugs for pediatric patients

The U.S. Food and Drug Administration today approved supplemental applications for Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) to...