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

Apr 15, 2016, 14:00 ET Nevro Receives FDA Approval for New Surgical Leads for the Senza® Spinal Cord Stimulation System Delivering HF10™ Therapy

Nevro Corp. (NYSE:NVRO), a global medical device company that is providing innovative evidence-based solutions for the treatment of chronic pain,...


Apr 14, 2016, 10:11 ET La FDA aprueba la fortificación de la harina de maíz con ácido fólico

El día de hoy, la Administración de Alimentos y Medicamentos de los Estados Unidos (FDA, por sus siglas en inglés) aprobó la...


Apr 14, 2016, 09:40 ET FDA approves folic acid fortification of corn masa flour

The U.S. Food and Drug Administration today approved folic acid fortification of corn masa flour. The approval allows manufacturers to...


Apr 12, 2016, 18:34 ET DURECT Announces FDA Acceptance of REMOXY® NDA, PDUFA Date of September 25, 2016

 DURECT Corporation (Nasdaq: DRRX) today announced its licensee, Pain Therapeutics (Nasdaq: PTIE), has been informed by the U.S. Food and Drug...


Apr 12, 2016, 16:30 ET Telesta Therapeutics Corporate Update - Type A Meeting with the FDA Scheduled

MONTREAL, April 12, 2016 /PRNewswire/ - Telesta Therapeutics Inc. (TSX: TST) (PNK: BNHLF) today announced that a Type A meeting has been...


Apr 12, 2016, 13:32 ET TGV-Inhalonix Receives Orphan Drug Status for its Novel Antibiotic to Treat Resistant Infections in Cystic Fibrosis

TGV-Inhalonix, Inc., a New York-based pharmaceutical company, today announced that its new drug candidate for treating antibiotic-resistant...


Apr 12, 2016, 10:00 ET Stroke Prevention: BIOTRONIK Announces FDA Approval of BioMonitor 2 Insertable Cardiac Monitor

 BIOTRONIK, a leader in cardio- and endovascular medical technology, today announced Food and Drug Administration (FDA) approval of BioMonitor...


Apr 12, 2016, 07:30 ET Imprimis Pharmaceuticals Registers its Texas Facility with the FDA as an Outsourcing Facility

 Imprimis Pharmaceuticals, Inc. (NASDAQ: IMMY), a pharmaceutical company focused on the development and commercialization of proprietary and...


Apr 12, 2016, 06:00 ET Qbtech Launches Breakthrough Product

The US Food and Drug Administration (FDA) has cleared the ADHD test - QbCheck - developed by the Swedish company Qbtech to aid in the assessment...


Apr 12, 2016, 01:07 ET AbbVie Receives FDA Accelerated Approval of Venclexta™ (venetoclax) Tablets, the First BCL-2 Inhibitor in Relapsed/Refractory Chronic Lymphocytic Leukemia Patients with 17p Deletion

 AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has granted accelerated...


Apr 11, 2016, 16:31 ET AbbVie Receives FDA Accelerated Approval of Venclexta™ (venetoclax) Tablets, the First BCL-2 Inhibitor in Relapsed/Refractory Chronic Lymphocytic Leukemia Patients with 17p Deletion

 AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has granted accelerated...


Apr 11, 2016, 08:00 ET NewPhase Successfully Completed Small Mammal Pre-clinical Trials of a Cancer Treatment That Transforms Cancer to a Treatable Chronic Ailment

In his State of the Union address, President Obama proposed a "moonshot" to find a cure for cancer. He stated "For the loved ones we've all lost,...


Apr 07, 2016, 07:00 ET Monteris Medical Receives IDE Approval From FDA To Evaluate NeuroBlate® In Patients With Medically Refractory Epilepsy

 Monteris Medical announced the U.S. Food and Drug Administration (FDA) has approved the company's Investigational Device Exemption (IDE) to...


Apr 06, 2016, 16:00 ET Cipher Pharmaceuticals Announces Approvals of Astion Acquired Barrier Creams by Health Canada and the Medicines Evaluation Board

MISSISSAUGA, ON, April 6, 2016 /PRNewswire/ - Cipher Pharmaceuticals Inc. (NASDAQ:CPHR; TSX:CPH) ("Cipher" or "the Company") today announced...


Apr 06, 2016, 11:08 ET Prime Therapeutics Statement on U.S. Food and Drug Administration's Approval of Biosimilar Inflectra

The U.S. Food and Drug Administration's (FDA) approval yesterday of the second U.S. biosimilar, Inflectra™ (infliximab-dyyb), is a positive...


Apr 06, 2016, 10:17 ET CPC Scientific Successfully Passes 4th U.S. FDA Inspection

CPC Scientific is pleased to announce that the CPC Good Manufacturing Practice (GMP) facility in Hangzhou, China has successfully passed its fourth...


Apr 06, 2016, 09:51 ET Eximo Medical, an Accelmed portfolio Company, Announces the Successful Completion of a Multi-Center First-In-Human Trial in Europe with a Hybrid Catheter for Treating Complex Lesions in Peripheral Blood Vessels

Eximo Medical, a medical device company that is developing a laser system and unique catheters for the treatment of peripheral artery disease...


Apr 05, 2016, 13:01 ET Lupin Launches Generic Intermezzo® Sublingual Tablets in the US

Pharma Major Lupin Limited announced today that its US subsidiary, Lupin Pharmaceuticals Inc. (collectively Lupin) has launched the first product...


Apr 05, 2016, 09:02 ET DICOM Grid Announces FDA Approval Of Next Generation Cloud PACS And Zero-Footprint Diagnostic Viewer

 DICOM Grid, makers of the leading cloud-based, medical image management suite, today announced FDA approval and new features for managing,...


Apr 05, 2016, 08:05 ET ANI Pharmaceuticals Announces FDA Approval of Oxycodone Capsules, 5mg

 ANI Pharmaceuticals, Inc. ("ANI") (Nasdaq: ANIP) today announced that it has received approval from the U.S. Food and Drug Administration...


Apr 05, 2016, 05:47 ET Das HeartLight® System von CardioFocus erhält die FDA-Zulassung für die Behandlung von Vorhofflimmern (VF)

Bis heute wurden weltweit über 3.400 Patienten mit dem HeartLight System behandelt Validiert definitive klinische Ergebnisse der...


Apr 04, 2016, 18:49 ET HeartLight® de CardioFocus, aprobado por la FDA para el tratamiento de la fibrilación atrial

Más de 3.400 pacientes en todo el mundo han sido tratados con el sistema HeartLight hasta hoy Valida resultados clínicos definitivos del...


Apr 04, 2016, 14:05 ET Le système HeartLight® de CardioFocus obtient l'autorisation de la FDA pour le traitement de la fibrillation auriculaire (FA)

Jusqu'à présent plus de 3 400 patients à travers le monde ont été traités avec le système HeartLight Les...


Apr 04, 2016, 09:15 ET CardioFocus' HeartLight® System Granted FDA Approval for Treatment of Atrial Fibrillation (AF)

 CardioFocus, Inc. today announced that it has received premarket approval (PMA) from the U.S. Food and Drug Administration (FDA) for its...


Most Viewed