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

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...


Sep 14, 2017, 12:45 ET FDA approves first biosimilar for the treatment of cancer

The U.S. Food and Drug Administration today approved Mvasi (bevacizumab-awwb) as a biosimilar to Avastin (bevacizumab) for the treatment of...


Sep 14, 2017, 10:45 ET FDA permits marketing of mobile medical application for substance use disorder

Today, the U.S. Food and Drug Administration permitted marketing of the first mobile medical application to help treat substance use disorders...


Sep 14, 2017, 08:30 ET FDA Approves Two Ortho Clinical Diagnostics Specialty Hepatitis B Assays

Ortho Clinical Diagnostics (Ortho), a global leader of in vitro diagnostics, has received approval from the U.S. Food and Drug...


Sep 13, 2017, 15:53 ET GSK's Shingrix containing Agenus' QS-21 Stimulon® adjuvant receives Unanimous FDA Advisory Committee recommendation for approval

Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with a pipeline of immune checkpoint antibodies and cancer vaccines, announced today that...


Sep 13, 2017, 15:49 ET FDA Advisory Committee votes unanimously for Shingrix (HZ/su) in the US for prevention of herpes zoster (shingles) in adults ages 50 and over

GlaxoSmithKline plc (LSE/NYSE: GSK) announced today that the Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the US Food...


Sep 12, 2017, 22:00 ET U.S. FDA Accepts for Review Astellas' Supplemental New Drug Application for mirabegron for Use in Combination with solifenacin succinate 5 mg for the Treatment of Overactive Bladder

Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, "Astellas") announced today that the U.S. Food and Drug Administration...


Sep 12, 2017, 11:35 ET Douglas Medical Products Inc. Receives FDA 510(k) Clearance for the TUBETECH® IV Administration Set

Douglas Medical Products, Inc., a growing medical device company focused on contract manufacturing of IV Administration/Extension Sets and Enteral...


Sep 12, 2017, 09:09 ET Array BioPharma Announces FDA Acceptance For Review Of Binimetinib And Encorafenib New Drug Applications For Patients With Advanced BRAF-mutant Melanoma

Array BioPharma (Nasdaq: ARRY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its New Drug Applications...


Sep 12, 2017, 08:34 ET T.R.U.E. Test® Ready-To-Use Patch Test Receives FDA Approval For Pediatric Use

SmartPractice has received FDA approval for T.R.U.E. TEST (truetest.com) ready-to-use patch test panels for pediatric patients as young as 6 years...


Sep 11, 2017, 06:57 ET Merck KGaA, Darmstadt, Germany, Set to Join Forces with Project Data Sphere to Pioneer Global Oncology Big Data Alliance

Not intended for U.K. based media - Big data platform to help accelerate innovative discovery, development and delivery of new...


Sep 11, 2017, 01:00 ET Pharming Announces Conclusion of FDA End of Phase 2 Interactions on RUCONEST® for Prophylaxis of HAE

Pharming Group N.V. ("Pharming" or "the Company") (Euronext Amsterdam: PHARM) announced today that it has concluded its End-of-Phase 2...


Sep 08, 2017, 01:00 ET Regeneron and Sanofi Announce Cemiplimab (REGN2810) Has Received FDA Breakthrough Therapy Designation for Advanced Cutaneous Squamous Cell Carcinoma

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough...


Sep 07, 2017, 14:18 ET Assured Bites, Inc. Petition Approval Marks First-Ever FDA Qualified Health Claim Linking Early Peanut Introduction to Allergy Prevention

Assured Bites, Inc., a New York-based family health and wellness company on the forefront of peanut allergy prevention, is pleased to announce the...


Sep 07, 2017, 08:00 ET Spinal Resources, Inc.®'s Swedge Pedicle Screw System Receives FDA 510(k) Clearance

Spinal Resources, Inc.® (SRI) announced that it has received FDA 510(k) clearance for its Swedge™ Pedicle Screw System. This unique system offers...


Sep 07, 2017, 07:00 ET Global Health Solutions Announces Filing of FDA 510(k) Application for Antimicrobial Saturated Petrolatum Gauze

Global Health Solutions, a leader in innovative solutions for advanced wound care and dermatology, has announced filing of its 510(k) application...


Sep 06, 2017, 08:32 ET NeuroRx Awarded FDA Fast Track Designation for First Drug Regimen Targeting Suicide in Bipolar Depression

NeuroRx, a clinical stage biopharma company developing the first oral therapy for Acute Suicidal Ideation and Behavior (ASIB), has been granted...


Sep 06, 2017, 08:00 ET Actelion Receives FDA Approval Of TRACLEER® (bosentan) For Use In Pediatric Patients With Pulmonary Arterial Hypertension

Actelion Pharmaceuticals US, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, announced today that the U.S. Food and...


Sep 06, 2017, 08:00 ET NuVasive Receives FDA 510(k) Clearance For Leading EOS Innovation

NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive,...


Sep 05, 2017, 14:00 ET C4 Imaging Announces an Additional FDA 510(k) Clearance for its Positive-Signal MRI Marker - Sirius™

C4 Imaging LLC is pleased to announce an additional US Food and Drug Administration 510(k) clearance for its Sirius™ MRI Marker, a novel...


Sep 05, 2017, 13:47 ET FDA Approves Guerbet's Dotarem® (gadoterate meglumine) for Pediatric Patients Younger Than Two Years

Guerbet LLC USA, the US affiliate of the global specialist in contrast products and solutions for medical imaging, announced today that the US Food...