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

23 May, 2017, 19:35 ET FDA Approves Pembrolizumab for Pancreatic Cancers with Mismatch Repair Deficiency

In an unprecedented, fast-tracked review, the Food and Drug Administration (FDA) approved the use of pembrolizumab (anti-PDI) immunotherapy for...


23 May, 2017, 16:14 ET FDA approves first cancer treatment for any solid tumor with a specific genetic feature

The U.S. Food and Drug Administration today granted accelerated approval to a treatment for patients whose cancers have a specific genetic feature...


23 May, 2017, 06:30 ET Prometic Presents New Data on PBI-4050 and Plasminogen at the American Thoracic Society's 2017 International Conference

- PBI-4050 monotherapy and combination with nintedanib demonstrated promising results in the treatment of Idiopathic Pulmonary Fibrosis (IPF)...


22 May, 2017, 17:47 ET Sanofi and Regeneron Announce FDA Approval of Kevzara® (sarilumab) for the Treatment of Moderately to Severely Active Rheumatoid Arthritis in Adult Patients

Sanofi and Regeneron Pharmaceuticals, Inc. today announced the U.S. Food and Drug Administration (FDA) approval of Kevzara® (sarilumab) for the...


22 May, 2017, 17:45 ET Regeneron and Sanofi Announce FDA Approval of Kevzara® (sarilumab) for the Treatment of Moderately to Severely Active Rheumatoid Arthritis in Adult Patients

- Kevzara is now available to U.S. patients Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced the U.S. Food...


22 May, 2017, 13:19 ET EMED Partners with Global Pharma Leaders in New FDA 510(k) Clearance

EMED Technologies Corporation is pleased to announce the SCIg60 Infusion System has been granted expanded indications as the only Immune Globulin...


22 May, 2017, 11:12 ET FDA approves first drug to specifically treat giant cell arteritis

The U.S. Food and Drug Administration today expanded the approved use of subcutaneous Actemra (tocilizumab) to treat adults with giant cell...


22 May, 2017, 05:32 ET Physician Groups Applaud FDA for Thoughtful Draft Guidance on Interchangeability, Urge for Robust Data to Demonstrate Biosimilarity

Biologics Prescribers Collaborative (BPC) applauds the U.S. Food and Drug Administration (FDA) for its careful consideration of interchangeability...


19 May, 2017, 13:05 ET Second Drug Receives FDA Approval for Bladder Cancer Based on Research Led by NYU Langone

The U.S. Food and Drug Administration has granted accelerated approval to a second drug in less than a month for first-line treatment for advanced...


18 May, 2017, 09:00 ET Neo-Pure Adds Nuts To The Expanding List Of Validated Products Compatible With Its Food Safety Technology

Food safety company Agri-Neo today announced that its organic, non-thermal intervention, Neo-Pure, has been validated to achieve a 5-log pathogen...


17 May, 2017, 17:00 ET Merck KGaA, Darmstadt, Germany, and Pfizer to Present Data Highlighting Potential of Avelumab in Challenging Cancers at ASCO 2017

- A total of 13 abstracts across seven hard-to-treat cancers highlight the progress of avelumab as a monotherapy and potential novel...


17 May, 2017, 16:02 ET FDA expands approved use of Kalydeco to treat additional mutations of cystic fibrosis

The U.S. Food and Drug Administration today expanded the approved use of Kalydeco (ivacaftor) for treating cystic fibrosis. The approval triples...


17 May, 2017, 09:30 ET CrossBay Medical Announces FDA And CE Mark Marketing Authorizations For Its IVF Embryo Transfer Catheter Set

CrossBay Medical, Inc., today announced receipt of United States Food and Drug Administration (FDA) clearance of its product, the CrossBay IVF...


17 May, 2017, 02:30 ET FDA Grants Bayer Priority Review for Investigational Compound Copanlisib in Follicular Lymphoma

Bayer announced today that the U.S. Food and Drug Administration (FDA) has granted Priority Review designation for the New Drug Application (NDA)...


16 May, 2017, 16:50 ET Abon Received Approval from the US FDA for Clofarabine Injection

Abon Pharmaceuticals, LLC, a specialty pharmaceutical company, today announced that it has received final approval from the FDA for its Abbreviated...


16 May, 2017, 09:47 ET Glucose Meter Connecting Diabetes Patients To Trusted Care Team Approved In U.S. And Europe

Smart Meter, LLC announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and CE Mark in Europe to market...


16 May, 2017, 09:42 ET Top 5 Life Science News Stories of May 2017

This month, a new FDA commissioner was confirmed, a promising cancer drug delivered surprising clinical trial results, and China moved ahead of...


16 May, 2017, 09:37 ET Pharmadax Receives FDA Approval for a Generic Version of Seroquel XR®

Pharmadax Inc., a pharmaceutical company based in New Taipei City, Taiwan, and its subsidiary Pharmadax USA, Inc., based in Irvine, California,...


16 May, 2017, 07:30 ET Sangamo Receives Fast Track Designation From The FDA For SB-525 Investigational Hemophilia A Gene Therapy

Sangamo Therapeutics, Inc. (NASDAQ: SGMO) announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to...


16 May, 2017, 06:52 ET Lannett Announces Approval For Levocetirizine Dihydrochloride Oral Solution, 2.5 mg/5 mL (0.5 mg/mL)

Lannett Company, Inc. (NYSE: LCI) today announced that it received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New...


15 May, 2017, 12:09 ET Resverlogix recibe aprobación de la FDA para un ensayo clínico de Apabetalone

- Resverlogix recibe la aprobación de la División Cardiovascular y Renal de la FDA para proceder a un ensayo clínico solicitado de Apabetalone...


15 May, 2017, 12:02 ET Body Vision Medical Receives FDA Clearance for the LungVision Navigation System, Revolutionizing the Areas of Lung Cancer Detection and Treatment

Body Vision Medical, a medical device company specializing in augmented real-time imaging, announced today that it has received clearance from the...


15 May, 2017, 09:35 ET Resverlogix Receives Approval From The FDA Cardiovascular and Renal Division To Proceed With A Requested Apabetalone Clinical Trial

Apabetalone expands to a second major clinical indication in kidney dialysis patients CALGARY, May 15, 2017 /PRNewswire/ - Resverlogix Corp....


15 May, 2017, 08:00 ET Glenmark Pharmaceuticals to Initiate Clinical Study for GBR 1342, Second Investigational New Drug from Immuno-Oncology Portfolio

Glenmark Pharmaceuticals, a global pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) cleared the company's...


15 May, 2017, 07:36 ET Nuvo Pharmaceuticals™ Inc. Announces Topline Results from European Ankle Sprain Study with Pennsaid® 2%

- Pennsaid 2% Already Approved for Marketing in the United States and Russia - MISSISSAUGA, ON, May 15, 2017 /PRNewswire/ - Nuvo Pharmaceuticals...