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

Mar 28, 2017, 13:50 ET Regeneron and Sanofi to Host Investor Conference Call to Discuss DUPIXENT® (dupilumab) Approval

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi will hold a conference call for the financial community to discuss the U.S. Food and Drug...


Mar 28, 2017, 11:47 ET FDA approves new eczema drug Dupixent

The U.S. Food and Drug Administration today approved Dupixent (dupilumab) injection to treat adults with moderate-to-severe eczema (atopic...


Mar 28, 2017, 11:40 ET Regeneron and Sanofi Announce FDA Approval of DUPIXENT® (dupilumab), the First Targeted Biologic Therapy for Adults with Moderate-to-Severe Atopic Dermatitis

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) approved DUPIXENT®...


Mar 28, 2017, 11:40 ET Sanofi and Regeneron Announce FDA Approval of Dupixent® (dupilumab), the First Targeted Biologic Therapy for Adults with Moderate-to-Severe Atopic Dermatitis

Sanofi and Regeneron Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) approved Dupixent® (dupilumab)...


Mar 28, 2017, 11:17 ET FDA approves first-in-human trial for neural-enabled prosthetic hand system developed at FIU

Upper extremity amputees are one step closer to successfully picking up a cookie and an egg, thanks to a new advanced prosthetic system that is...


Mar 28, 2017, 10:37 ET Synergy MedSales, Inc. Introduces Newly FDA-Approved Forma-TK Lasers

SYNERGY MEDSALES, INC., a global leader in aesthetic device sales, has announced that it has signed an agreement with FormaTK Systems Ltd. to...


Mar 27, 2017, 16:14 ET FDA approves maintenance treatment for recurrent epithelial ovarian, fallopian tube or primary peritoneal cancers

The U.S. Food and Drug Administration today approved Zejula (niraparib) for the maintenance treatment (intended to delay cancer growth) of adult...


Mar 27, 2017, 15:47 ET TESARO Announces U.S. FDA Approval Of ZEJULA™ (Niraparib) For Women With Recurrent Ovarian Cancer

TESARO, Inc. (NASDAQ: TSRO), an oncology-focused biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has...


Mar 27, 2017, 08:58 ET TyrNovo, a Kitov company, to Present Preclinical Data at the American Association for Cancer Research Annual Meeting

Combined treatment of TyrNovo's NT219 with targeted cancer drugs overcame acquired resistance of colon, lung, and head-and-neck cancers in PDX...


Mar 27, 2017, 08:00 ET iCAD Receives FDA Approval For PowerLook Tomo Detection

iCAD (Nasdaq: ICAD), an industry-leading provider of advanced image analysis, workflow solutions and radiation therapy for the early...


Mar 23, 2017, 21:15 ET Surgery Without the Knife: Mirabilis Medical Announces European Approval for Non-Invasive Uterine Fibroid Treatment

Mirabilis Medical, a Seattle-area developer of advanced medical technology for non-invasive surgery, announced today CE Mark authorization for...


Mar 23, 2017, 17:30 ET FDA Grants Approval for BAVENCIO® (avelumab), the First Immunotherapy Approved for Metastatic Merkel Cell Carcinoma

EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Inc. (NYSE: PFE) today announced that...


Mar 23, 2017, 14:49 ET FDA approves first treatment for rare form of skin cancer

The U.S. Food and Drug Administration today granted accelerated approval to Bavencio (avelumab) for the treatment of adults and pediatric patients...


Mar 23, 2017, 10:15 ET FDA Provides Cornerstone Pharmaceuticals Approval to Initiate Pivotal Study for CPI-613, its Metabolism-Directed Anticancer Compound

Cornerstone Pharmaceuticals, Inc., a clinical-stage, oncology-focused pharmaceutical company, announced a major milestone today. Following...


Mar 23, 2017, 08:30 ET Gamida Cell Receives Additional EMA Orphan Drug Designation for NiCord® in Haematopoietic Stem Cell Transplantation (HSCT)

Gamida Cell, a leader in cellular and immune therapies for the treatment of cancer and orphan genetic diseases, announced today that orphan drug...


Mar 23, 2017, 08:00 ET Symbiomix Therapeutics Announces FDA's Acceptance of New Drug Application for Solosec™ with Priority Review Status

Symbiomix today announced that the US Food and Drug Administration (FDA) has accepted for filing the Company's New Drug Application (NDA) for its...


Mar 23, 2017, 07:30 ET Medicure Announces FDA Approval for Apicore's Generic Tetrabenazine

WINNIPEG, March 23, 2017 /PRNewswire/ - Medicure Inc. ("Medicure" or the "Company") (TSXV:MPH, OTC:MCUJF), a leading Canadian specialty...


Mar 23, 2017, 07:00 ET BioLineRx Announces Acquisition of Agalimmune Ltd. to Accelerate Expansion of Immuno-Oncology Pipeline

BioLineRx Ltd. (NASDAQ/TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology and immunology, announced today that it has...


Mar 22, 2017, 09:00 ET Newton-Wellesley Hospital's Early Detection Initiative Improves Clinical Outcomes, Reduces Nurse Alarm Response Time by 59%

EarlySense, the market leader in Contact-Free Continuous Monitoring solutions, announced today that Newton-Wellesley Hospital, a nationally...


Mar 21, 2017, 15:17 ET FDA approves drug to treat Parkinson's disease

The U.S. Food and Drug Administration today approved Xadago (safinamide) tablets as an add-on treatment for patients with Parkinson's disease who...


Mar 21, 2017, 09:00 ET Tarrex Biopharma Announces FDA Acceptance of IND Application for TX803 to Commence Phase I Clinical Trials in Colorectal Cancer Patients

Tarrex Biopharma, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company's Investigational New Drug (IND)...


Mar 20, 2017, 13:14 ET Mylan Receives Tentative Approval for "TLE400" Under PEPFAR

Mylan N.V. (NASDAQ, TASE: MYL), a leading global pharmaceutical company, today announced receipt of tentative approval from the U.S. Food and Drug...


Mar 20, 2017, 08:00 ET Trovita Health Science Announces FDA Marketing Clearance of New SAFE-T FEED™ Nutrition Delivery Device for Tube Feeding

Trovita Health Science, an emerging life science company specializing in medical nutrition, announces U.S. Food and Drug Administration marketing...


Mar 20, 2017, 07:31 ET JUVÉDERM VOLLURE™ XC Approved by U.S. FDA for Correction of Facial Wrinkles and Folds in Adults over the Age of 21

Allergan plc, (NYSE: AGN), a leading global pharmaceutical company, today announced that the company has received approval from the U.S. Food and...