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

Jul 17, 2017, 09:07 ET Perrigo Announces FDA Final Approval For Its First-To-File Ab Rated Generic Version Of Androgel® Topical Gel, 1.62% Packets

Perrigo Company plc (NYSE; TASE: PRGO) today announced it has received final approval from the U.S. Food and Drug Administration for its AB rated...


Jul 17, 2017, 07:30 ET Impax Announces FDA Approval of its AB Rated Generic Concerta® (Methylphenidate Hydrochloride) Extended-Release Tablets CII

Impax Laboratories, Inc. (NASDAQ: IPXL), a specialty pharmaceutical company, today announced it has received an AB therapeutic equivalent rating...


Jul 14, 2017, 06:53 ET Lannett Receives Approval For Cyproheptadine Hydrochloride Syrup, 2 mg/5 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...


Jul 13, 2017, 16:10 ET Janssen Announces U.S. FDA Approval Of TREMFYA™ (Guselkumab) For The Treatment Of Moderate To Severe Plaque Psoriasis

Janssen Biotech, Inc.(Janssen) announced today that the U.S. Food and Drug Administration (FDA) has approved TREMFYA™ (guselkumab) for the...


Jul 13, 2017, 09:00 ET Philips receives U.S. FDA 510(k) clearance to market its Philips BlueControl, a wearable light therapy device to treat mild psoriasis at home

Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced it has received 510(k) clearance from the U.S. Food and...


Jul 12, 2017, 17:25 ET Novartis CAR-T cell therapy CTL019 unanimously (10-0) recommended for approval by FDA advisory committee to treat pediatric, young adult r/r B-cell ALL

Novartis announced today that the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) unanimously (10-0) recommended...


Jul 12, 2017, 16:27 ET AMCP-Supported Bill to Create Safe Harbor for Pre-FDA-Approval Product Communications is Examined in House Subcommittee on Health Hearing

The U.S. House Energy and Commerce Committee's Subcommittee on Health held a hearing today on the "Pharmaceutical Information Exchange (PIE) Act of...


Jul 12, 2017, 08:11 ET Saebo Announces FDA Clearance of SaeboVR - World's First Virtual ADL Rehabilitation System

Saebo, Inc. announced on Wednesday that the U.S. Food and Drug Administration (FDA) has cleared SaeboVR, a virtual ADL (activities of daily living)...


Jul 12, 2017, 07:30 ET Oxitec's Friendly™ Aedes Mosquito Receives Positive Evaluation for European Standard in relation to Human Health and the Environment

The National Institute of Public Health and the Environment (RIVM) in the Netherlands today published its "Technical evaluation of a potential...


Jul 12, 2017, 07:30 ET El mosquito Aedes Amigable™ de Oxitec recibe una evaluación positiva para el Estándar Europeo relacionado con la Salud Humana y el Medio Ambiente

El Instituto Nacional de Salud Pública y Medio Ambiente (RIVM) de los Países Bajos ha publicado hoy su «Evaluación técnica de una liberación...


Jul 11, 2017, 19:22 ET FDA Grants Full Approval for BLINCYTO® (blinatumomab) to Treat Relapsed or Refractory B-cell Precursor Acute Lymphoblastic Leukemia in Adults and Children

Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application...


Jul 11, 2017, 14:07 ET Dornier MedTech Launches the DORNIER DELTA® III - Most Advanced Kidney Stone Treatment Lithotripter

Dornier MedTech® America, a global medical device company and the pioneer of Extracorporeal Shock Wave Lithotripsy (ESWL®), has received FDA...


Jul 11, 2017, 09:00 ET Stryker's MultiGen® 2 Radiofrequency Generator Receives FDA 510(k) Clearance

Stryker announced today that it has received FDA 510(k) clearance for its MultiGen 2 RF Generator. This product provides physicians with the...


Jul 11, 2017, 07:07 ET FDA Clears Pesticide-Free Resultz® Lice & Egg Elimination Kit

Piedmont Pharmaceuticals announces it has received clearance from the U.S. Food and Drug Administration for its patented, pesticide-free RESULTZ®...


Jul 07, 2017, 15:57 ET The U.S. Food & Drug Administration Approves Endari™ (L-glutamine oral powder), the First and Only Treatment for Sickle Cell Disease in Pediatric Patients and First in Nearly 20 Years for Adults

Emmaus Life Sciences Inc. announced today that the U.S. Food and Drug Administration (FDA) approved Endari™ (L-glutamine oral powder) to reduce the...


Jul 07, 2017, 11:40 ET FDA approves new treatment for sickle cell disease

The U.S. Food and Drug Administration today approved Endari (L-glutamine oral powder) for patients age five years and older with sickle cell...


Jul 06, 2017, 18:07 ET BMS' Orencia Plunges into the Fray of Battle for Alternative MOA for Psoriatic Arthritis with Recent FDA Approval.... Can it Find a Unique Space to Play?

BMS' Orencia, already indicated for Rheumatoid Arthritis, gained FDA approval for use in patients with Psoriatic Arthritis (PsA). In RealTime...


Jul 05, 2017, 17:02 ET Impax Announces FDA Approval and Launch of Additional Strengths of Generic Focalin XR® (Dexmethylphenidate Hydrochloride) Extended-Release Capsules CII

Impax Laboratories, Inc. (NASDAQ: IPXL), a specialty pharmaceutical company, today announced it has received final U.S. Food and Drug...


Jul 05, 2017, 14:37 ET Breckenridge Announces Final Approval for Omeprazole Delayed-Release Capsules

Breckenridge Pharmaceutical, Inc. announced today it has received U.S. Food and Drug Administration final approval of its abbreviated new drug...


Jul 05, 2017, 09:00 ET Edwards' INSPIRIS RESILIA Valve Receives FDA Approval

Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical...