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.

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Sep 22, 2017, 08:00 ET Abbott Secures FDA Approval for MRI-Compatibility for the Company's Ellipse™ ICD

Abbott (NYSE: ABT) today announced U.S. Food and Drug Administration (FDA) approval for magnetic resonance (MR)-conditional labeling for one of...


Sep 21, 2017, 09:29 ET Perrigo Announces FDA Final Approval For Its AB Rated Generic Version Of Exalgo® 32mg Extended Release Tablets

Perrigo Company plc (NYSE; TASE: PRGO) today announced it has received final approval from the U.S. Food and Drug Administration for its AB rated...


Sep 21, 2017, 09:00 ET FDA Releases Cefaly® for Acute Treatment of Migraine Attacks

CEFALY Technology announces today that on Friday, September 15th, the U.S. Food and Drug Administration (FDA) released the use of a new Cefaly®...


Sep 21, 2017, 03:13 ET European Commission Approves Bavencio (avelumab) for Metastatic Merkel Cell Carcinoma

Not intended for UK-based media - First approved immunotherapy for rare and aggressive skin cancer in the European Union, with...


Sep 20, 2017, 14:07 ET PhaseRx Receives Orphan Drug Designation from FDA for PRX-ASL for the Treatment of Argininosuccinate Lyase Deficiency

PhaseRx, Inc. (NASDAQ: PZRX), a biopharmaceutical company developing mRNA treatments for life-threatening inherited liver diseases in children,...


Sep 19, 2017, 12:30 ET Sancilio Pharmaceuticals Company, Inc. (SPCI) Receives Rare Pediatric Disease Designation From the US Food and Drug Administration for Altemia a Treatment of Sickle Cell Disease (SCD) in Children

Sancilio Pharmaceuticals Company, Inc. (SPCI) today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease...


Sep 19, 2017, 11:16 ET Arkis BioSciences® Achieves FDA Clearance of its CerebroFlo™ EVD Catheter with Endexo® Technology

Arkis BioSciences, a leading innovator in minimally invasive surgical instrumentation, has obtained FDA clearance of its new external ventricular...


Sep 19, 2017, 08:30 ET Theravance Biopharma Highlights Approval of Trelegy Ellipta (Closed Triple) as the First Once-Daily Single Inhaler Triple Therapy for the Treatment of Appropriate Patients with COPD in the US

Theravance Biopharma, Inc. (NASDAQ: TBPH) ("Theravance Biopharma") today highlighted that the US Food and Drug Administration (FDA) has approved...


Sep 19, 2017, 07:30 ET Estudo demonstra potencial de fremanezumabe para atender as necessidades de pacientes com enxaqueca crônica e episódica

A Teva Farmacêutica Ltda. apresentou dados que avaliam o fremanezumabe, um tratamento em investigação para a profilaxia de enxaqueca no 18º...


Sep 18, 2017, 23:20 ET Camurus annonce que la FDA a accordé l'examen prioritaire de la demande d'autorisation du traitement CAM2038

La FDA a fixé une date butoir en vertu de la PDUFA au 19 janvier 2018 pour la demande d'autorisation de l'injection de dépôts hebdomadaires et...


Sep 18, 2017, 20:30 ET Trelegy Ellipta approved as the first once-daily single inhaler triple therapy for the treatment of appropriate patients with COPD in the US

GlaxoSmithKline plc (LSE/NYSE: GSK) and Innoviva, Inc. (NASDAQ: INVA) today announced that the US Food and Drug Administration (FDA) has approved...


Sep 18, 2017, 10:07 ET ARKRAY launches ADAMS™ A1c HA-8180V System for hemoglobin A1c testing

U.S. ARKRAY, Inc. (ARKRAY) announces the launch of the ADAMS™ A1c HA-8180V System for hemoglobin A1c testing. The system obtained FDA 510(k)...


Sep 18, 2017, 09:52 ET Camurus: FDA stimmt für vorrangige Prüfung des NDA-Antrags für wöchentliche und monatliche CAM2038 Buprenorphin-Depots zur Behandlung von Opioidkonsumstörung

FDA legt PDUFA-Entscheidungstermin auf den 19. Januar 2018 Camurus (NASDAQ STO: CAMX) hat bekanntgegeben, dass die US-amerikanische Food and...


Sep 18, 2017, 08:45 ET Perrigo Announces Tentative FDA Approval For The Generic Version Of Acanya® Gel

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


Sep 18, 2017, 08:15 ET Varian Expands Clinicians' Cancer-fighting Toolkit with Eclipse 15.5

Varian Medical Systems (NYSE: VAR) today announced the newest release of its treatment planning system, Eclipse 15.5. This new release has received...


Sep 18, 2017, 08:02 ET Camurus anuncia que la FDA concede una revisión prioritaria de NDA para los depósitos de buprenorfina CAM2038 semanales y mensuales para el tratamiento de la enfermedad de uso opioide

La FDA ha asignado una fecha de objetivo PDUFA para el 19 de enero de 2018 Camurus (NASDAQ STO: CAMX) anuncia que la Administración de...


Sep 18, 2017, 08:00 ET DelMar Pharmaceuticals Receives IND Allowance from FDA to Initiate Clinical Trials of VAL-083 for the Treatment of Ovarian Cancer

DelMar Pharmaceuticals, Inc. (Nasdaq: DMPI) ("DelMar" and "the Company"), a biopharmaceutical company focused on the development of new cancer...


Sep 18, 2017, 07:30 ET Genentech Receives Blow by FDA in Cancer Drug Avastin Biosimilar Battle, an Industrial Info News Alert

Researched by Annette Kreuger, Industrial Info Resources --Biological drug maker Genentech, the developer of the blockbuster cancer drug Avastin,...


Sep 18, 2017, 04:17 ET 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...


Sep 15, 2017, 01:00 ET New indication for BRIVIACT® (brivaracetam): UCB's newest antiepileptic drug approved by FDA as monotherapy treatment of partial-onset seizures in adults

UCB announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for BRIVIACT®...


Sep 14, 2017, 19:50 ET CSL Behring Announces FDA Approval of Privigen® [Immune Globulin Intravenous (Human), 10% Liquid] for the Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) in Adults

Global biotherapeutics leader CSL Behring today announced that the U.S. Food and Drug Administration (FDA) has approved Privigen® [Immune Globulin...


Sep 14, 2017, 17:10 ET Bayer Receives FDA Approval for Aliqopa™ (copanlisib) 60 mg vial for Injection in Adults with Relapsed Follicular Lymphoma after Two Prior Systemic Therapies

Bayer announced today that the U.S. Food and Drug Administration (FDA) has approved Aliqopa™ (copanlisib) for the treatment of adult patients...


Sep 14, 2017, 16:33 ET Pear Therapeutics Obtains FDA Clearance of the First Prescription Digital Therapeutic to Treat Disease

Pear Therapeutics, the leader in a new era of prescription digital therapeutics, today announced that the U.S. Food and Drug Administration (FDA)...


Sep 14, 2017, 14:54 ET FDA Approves Amgen And Allergan's MVASI™ (bevacizumab-awwb) For The Treatment Of Five Types Of Cancer

Amgen (NASDAQ: AMGN) and Allergan plc. (NYSE: AGN) today announced that the U.S. Food and Drug Administration (FDA) has approved MVASI™...


Sep 14, 2017, 13:58 ET FDA approves new treatment for adults with relapsed follicular lymphoma

The U.S. Food and Drug Administration today granted accelerated approval to Aliqopa (copanlisib) for the treatment of adults with relapsed...


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