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

Oct 05, 2017, 07:00 ET Neurocrine Announces FDA Approval of 80 mg INGREZZA® (valbenazine) Capsules for the Treatment of Adults with Tardive Dyskinesia (TD)

Neurocrine Biosciences, Inc. (NASDAQ: NBIX) announced today that the U.S. Food and Drug Administration (FDA) has approved an 80 mg INGREZZA®...


Oct 04, 2017, 17:16 ET Solta Medical Receives FDA 510(k) Clearance for Thermage FLX™ System, Newest Generation Skin Smoothing Technology

Solta Medical, a division of Valeant Pharmaceuticals North America LLC, announced today that its Thermage FLX™ System received 510(k) clearance...


Oct 04, 2017, 16:16 ET FDA Grants Marketing Clearance for the Peerbridge Cor™ Multi-channel Remote ECG Monitor

Peerbridge Health Inc., a Health IT company, announced today that its first product, the Peerbridge Cor™ System -- a wireless electrocardiogram...


Oct 04, 2017, 13:00 ET Transfer of Regulatory Jurisdiction for Oxitec's Self-limiting Friendly™ Aedes in the United States

FDA issues final Guidance for Industry, transferring regulatory authority to EPA Following new Guidance issued by the U.S. Food and Drug...


Oct 04, 2017, 11:02 ET Intellijoint Surgical Inc. Receives CE Mark Approval for Flagship Product intellijoint HIP®

WATERLOO, ON, Oct. 4, 2017 /PRNewswire/ - Intellijoint Surgical®, a medical technology company, is pleased to announce that it has received the...


Oct 04, 2017, 09:54 ET FDA's Proposed Extension to New Food Labeling Rules and Why You Should Still Comply Now

On September 29, 2017, the U.S. Food and Drug Administration (FDA) proposed an extension of the compliance dates for the final rules mandating...


Oct 04, 2017, 09:00 ET Applied Spectral Imaging Launches Two New Products for the Digital Pathology Market

Applied Spectral Imaging (ASI), a global leader in computer-assisted biomedical imaging, announced today the launch of PathFusion™ and HiPath Pro™,...


Oct 04, 2017, 08:00 ET Solta Medical Receives FDA 510(k) Clearance for Thermage FLX™ System, Newest Generation Skin Smoothing Technology

New Thermage FLX™ System Reduces Treatment Time by 25 Percent and Enhances Patient Comfort Solta Medical, a division of Valeant...


Oct 04, 2017, 04:00 ET CALCIVIS Closes Equity Funding to Advance its CALCIVIS Imaging System to Market

CALCIVIS, a medical devices company focused on revolutionising the management of tooth decay and enabling preventive dentistry, announces it has...


Oct 03, 2017, 20:08 ET Mylan Announces U.S. FDA Approval of First Generic for Copaxone® 40 mg/mL 3-Times-a-Week and May Be Eligible for 180-Day Exclusivity

Mylan N.V. (NASDAQ, TASE: MYL) today announced that the U.S. Food and Drug Administration (FDA) has approved Mylan's Abbreviated New Drug...


Oct 03, 2017, 09:00 ET DiscGenics Receives FDA Allowance of IND to Commence Clinical Study of Its Degenerative Disc Disease Therapy

DiscGenics, Inc., a clinical stage regenerative medicine company focused on developing regenerative therapies that alleviate pain and restore...


Oct 03, 2017, 08:00 ET Roche to initiate testing for Babesia parasite at U.S. Blood Centers under FDA Investigational New Drug Application protocol

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced immediate plans to initiate screening of blood samples with the cobas® Babesia test under an...


Oct 03, 2017, 07:31 ET FDA Approves BOTOX® Cosmetic (OnabotulinumtoxinA) for the Temporary Improvement in the Appearance of Moderate to Severe Forehead Lines Associated with Frontalis Muscle Activity In Adults

Today Allergan plc (NYSE:AGN) announced the FDA approval of BOTOX® Cosmetic for its third indication, the temporary improvement in the appearance...


Oct 03, 2017, 07:00 ET FDA clears first over-the-counter (OTC) carbon monoxide breath sensor for use in smoking cessation programs

Carrot Inc. announced today that its Carbon Monoxide Breath Sensor System has been cleared by the U.S. Food and Drug Administration (FDA) for...


Oct 02, 2017, 16:05 ET QIAGEN Achieves ISO Certification for State-of-the-art Quality in Forensics

QIAGEN (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced that its manufacturing and supply chain for consumables and other products...


Oct 02, 2017, 12:39 ET Mylan Launches Generic Cancidas® for Injection

Mylan N.V. (NASDAQ, TASE: MYL) today announced the U.S. launch of Caspofungin Acetate for Injection, one of the first generic versions of Merck's...


Oct 02, 2017, 08:00 ET FDA Accepts Supplemental New Drug Application (sNDA) filing for AVYCAZ® (ceftazidime and avibactam)

Allergan plc (NYSE: AGN), a leading global pharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has accepted a...


Oct 02, 2017, 07:00 ET Alere Receives FDA Clearance for Alere™ i Influenza A & B 2 Rapid Molecular Test

Alere Inc. (NYSE: ALR), a global leader in rapid diagnostics, today announced that its Alere™ i Influenza A & B 2 test has received 510(k)...


Oct 02, 2017, 06:56 ET Lannett Receives Two FDA Approvals For Lansoprazole Delayed-Release Capsules USP, One Each For Full Prescription And OTC

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


Sep 29, 2017, 16:59 ET Mylan Launches Generic Gleevec® Tablets

Mylan N.V. (NASDAQ, TASE: MYL) today announced the U.S. launch of Imatinib Mesylate Tablets, 100 mg and 400 mg, a generic version of Novartis's...


Sep 29, 2017, 11:03 ET Novo Nordisk Receives FDA Approval for Fiasp®, a New Fast-Acting Mealtime Insulin

Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) approved Fiasp® (insulin aspart injection) 100 Units/mL, a...


Sep 28, 2017, 14:25 ET FDA approves new treatment for certain advanced or metastatic breast cancers

The U.S. Food and Drug Administration today approved Verzenio (abemaciclib) to treat adult patients who have hormone receptor (HR)-positive, human...


Sep 28, 2017, 09:00 ET EOI Announces FDA Clearance for the FLXfit15, the Only 3D Articulated Expandable Cage With 15 degrees of Lordosis Correction

Expanding Orthopedics Inc. (EOI), a privately-held medical device company focused on developing and commercializing innovative expandable devices...


Sep 28, 2017, 07:00 ET Impopharma Inc. and Breckenridge Pharmaceutical Inc. Enter Into an Asset-Purchase Agreement to Commercialize the Generic Version of a Leading Corticosteroid Product Upon FDA Approval

Impopharma Inc. ("Impopharma") today announced that it has entered into an asset purchase, license, and commercialization agreement with...


Sep 27, 2017, 17:42 ET No More Routine Finger Sticks(1) for Americans with Diabetes: Abbott′s FreeStyle® Libre Approved in the U.S.

Abbott (NYSE: ABT) today announced that the U.S. Food and Drug Administration (FDA) has approved the FreeStyle® Libre Flash Glucose Monitoring...