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

26 May, 2017, 16:02 ET Novartis receives FDA approval for expanded use of Zykadia® in first-line ALK-positive metastatic non-small cell lung cancer (NSCLC)

Novartis today announced the US Food and Drug Administration (FDA) approved the expanded use of Zykadia® (ceritinib) to include the first-line...


26 May, 2017, 11:15 ET PV (Pharmacovigilance) Audit Strategy Planning Workshop: Understand the Requirements for a Risk Based Audit Program and Current Interpretation (San Francisco, CA, United States - November 9-10, 2017) - Research and Markets

Research and Markets has announced the addition of the "PV (Pharmacovigilance) Audit Strategy Planning - A Practical Approach to Design and...


26 May, 2017, 11:00 ET Quality Control Laboratory Compliance Seminar with Focus on cGMPs and GLPs (San Francisco, CA, United States - November 9-10, 2017) - Research and Markets

Research and Markets has announced the addition of the "Quality Control Laboratory Compliance - cGMPs and GLPs: One and a Half-day In-person...


24 May, 2017, 16:05 ET CalciMedica Receives Fast-Track Designation for CM4620, a Novel CRAC Channel Inhibitor to Treat Acute Pancreatitis

Privately-held CalciMedica, Inc., announced today that it received Fast-Track designation from the U.S. Food and Drug Administration (US FDA) for...


24 May, 2017, 12:43 ET Athenex and Its Partner, Guangzhou Xiangxue Pharmaceutical, Announced Chinese FDA IND Approval to Begin Clinical Trials of KX-02 Tablet for Glioblastoma

Athenex, Inc., Buffalo, NY, a global specialty oncology pharmaceutical company focusing on the development and commercialization of next generation...


24 May, 2017, 09:01 ET ASI's Advanced Algorithms Automatically Interpret PD-L1 Assays

Applied Spectral Imaging (ASI), a global leader in computer-assisted image analysis platforms, introduces HiPath for analysis of PD-L1...


24 May, 2017, 08:03 ET Sun Pharma Announces US FDA Filing Acceptance of Biologics License Application (BLA) For Tildrakizumab

Sun Pharmaceutical Industries Ltd (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, "Sun Pharma" and includes its subsidiaries or...


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,...