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 20, 2017, 14:14 ET FDA clears first neonatal magnetic resonance imaging device

Today, the U.S. Food and Drug Administration cleared the first magnetic resonance imaging (MRI) device specifically for neonatal brain and head...


Jul 20, 2017, 03:00 ET LEO Pharma Receives Marketing Authorisation for Kyntheum® (Brodalumab), a New Biologic for the Treatment of Moderate-to-Severe Plaque Psoriasis in the European Union

LEO Pharma today announced that the European Commission has granted marketing authorisation for Kyntheum® (brodalumab), a new biologic for the...


Jul 19, 2017, 10:30 ET Fewer Leads, Fewer Complications: BIOTRONIK US Launches Proven DX Technology for Heart Failure Patients

BIOTRONIK today announced FDA approval and availability of the Intica DX and Intica cardiac resynchronization therapy (CRT)-DX implantable...


Jul 19, 2017, 09:30 ET FDA Accepts CSL Behring's Supplemental Biologics License Application for Hizentra® Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Indication

Global biotherapeutics leader CSL Behring today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company's...


Jul 19, 2017, 08:57 ET Perrigo Announces FDA Final Approval For Its AB Rated Generic Version Of DermOtic® Oil, 0.01% Ear Drops

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 19, 2017, 06:59 ET BD Receives FDA 510(k) Clearance for New Immunological Diagnostic System

BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced that it has received 510(k) clearance...


Jul 18, 2017, 16:28 ET Integrated Functional Electrical Stimulation Combined with Robotics Improves Clinical Outcomes

Reha Technology USA Inc. is pleased to announce that starting from June 2017, it offers an FDA approved integrated Functional Electronic...


Jul 18, 2017, 14:08 ET FDA approves Vosevi for Hepatitis C

The U.S. Food and Drug Administration today approved Vosevi to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis...


Jul 18, 2017, 08:30 ET B R A H M S PCT Joins the Fight Against Antibiotic-Resistant Organisms

B·R·A·H·M·S GmbH, a part of Thermo Fisher Scientific Inc., today announced it has received 510(k) clearance from the U.S. Food and Drug...


Jul 18, 2017, 08:00 ET Capricor Receives Rare Pediatric Disease Designation from FDA for CAP-1002 for Patients with Duchenne Muscular Dystrophy

Capricor Therapeutics, Inc. (NASDAQ: CAPR), a biotechnology company developing biological therapies for Duchenne muscular dystrophy and other rare...


Jul 18, 2017, 07:00 ET U.S. FDA Designates Mallinckrodt's StrataGraft® as Regenerative Medicine Advanced Therapy

Mallinckrodt plc (NYSE: MNK), a leading global specialty pharmaceutical company, today announced that StrataGraft® regenerative skin tissue is...


Jul 17, 2017, 17:44 ET FDA approves new treatment to reduce the risk of breast cancer returning

The U.S. Food and Drug Administration today approved Nerlynx (neratinib) for the extended adjuvant treatment of early-stage, HER2-positive breast...


Jul 17, 2017, 14:06 ET CSA Medical Announces FDA (510K) clearance of truFreeze® System, RapidAV spray catheter

CSA Medical announced on Monday, an advancement of its catheter technology with the expansion of its truFreeze® catheter offerings to include a...


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...