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

Aug 17, 2018, 10:03 ETFDA permits marketing of transcranial magnetic stimulation for treatment of obsessive compulsive disorder

Today, the U.S. Food and Drug Administration permitted marketing of the Brainsway Deep Transcranial Magnetic Stimulation System for treatment of...


Aug 17, 2018, 08:00 ETEisai And Merck Announce FDA Approval Of LENVIMA® (lenvatinib) Capsules For First-Line Treatment Of Unresectable Hepatocellular Carcinoma (HCC)

Eisai Inc. and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the U.S. Food and Drug Administration...


Aug 17, 2018, 07:00 ETFDA Approves EYLEA® (aflibercept) Injection sBLA in Wet Age-related Macular Degeneration

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics ...


Aug 16, 2018, 16:11 ETEisai And Merck Announce FDA Approval Of LENVIMA® (lenvatinib) Capsules For First-line Treatment Of Unresectable Hepatocellular Carcinoma (HCC)

Eisai Inc. and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the U.S. Food and Drug Administration...


Aug 16, 2018, 13:22 ETFDA approves first generic version of EpiPen

The U.S. Food and Drug Administration today approved the first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector for the emergency...


Aug 16, 2018, 09:18 ETSirnaomics Oncology IND Receives Green Light from US FDA to Initiate Study for Treatment of Cholangiocarcinoma

Sirnaomics, Inc. (http://new.sirnaomics.com), a leading biopharmaceutical company in discovery and development of RNAi therapeutics, announces today...


Aug 16, 2018, 08:00 ETGrifols Achieves Key Milestone with FDA Approval of the New Consolidated Manufacturing Facility (CMF) for Production of Recombinant Proteins

Grifols (MCE: GRF, MCE: GRF.P and NASDAQ: GRFS), a global healthcare company with a history of more than 75 years of improving people's health and...


Aug 14, 2018, 09:00 ETMolecuLight® Inc.'s first-of-its-kind handheld fluorescence imaging device receives FDA De Novo clearance for US wound care market

TORONTO, Aug. 14, 2018 /PRNewswire/ - MolecuLight Inc. achieved a major regulatory milestone permitting expansion into the United States market. FDA...


Aug 14, 2018, 09:00 ETEarlySense Successfully Detects Opioid-Induced Respiratory Depression, New Study Shows

EarlySense, the market leader in contact-free continuous monitoring solutions across the care continuum, today announced that its system has been...


Aug 14, 2018, 08:42 ETFDA Approvals for Cardiac Electrophysiology Products Bright Spot in Healthcare Industry

MarketNewsUpdates.com News Commentary The rising prevalence of cardiac conditions such as flutter, atrial fibrillation and arrhythmia has driven the...


Aug 14, 2018, 08:00 ETProcleix® Zika Virus Assay Approved by the FDA for Blood Screening on the Procleix® Panther® System

Grifols (MCE: GRF, MCE: GRF.P and NASDAQ: GRFS), a leading global producer of plasma-derived medicines and a leader in the development of innovative...


Aug 14, 2018, 07:14 ETInova Diagnostics Receives FDA Clearance for Test to Detect Antibodies to HMGCR

Inova Diagnostics, a world leader in autoimmune disease diagnostic systems and reagents for the clinical laboratory, is pleased to announce the...


Aug 13, 2018, 11:30 ETMedicure Announces FDA Approval of Acute Care Cardiovascular Drug Sodium Nitroprusside Injection

WINNIPEG, Aug. 13, 2018 /PRNewswire/ - Medicure Inc. ("Medicure" or the "Company") (TSXV:MPH, OTC:MCUJF), a cardiovascular pharmaceutical company, is ...


Aug 13, 2018, 10:56 ETMylan Launches First Generic for Adcirca® Tablets

Global pharmaceutical company Mylan N.V. (NASDAQ: MYL) today announced the U.S. launch of Tadalafil Tablets USP, 20 mg, the first generic version of...


Aug 13, 2018, 09:47 ETOrsini Healthcare Specialty Pharmacy Selected by Alnylam Pharmaceuticals to Distribute ONPATTRO™ (patisiran)

Orsini Healthcare Specialty Pharmacy announced that it has been selected by Alnylam Pharmaceuticals, Inc to distribute ONPATTRO™ (patisiran) lipid...


Aug 13, 2018, 09:47 ETUS Food And Drug Administration (FDA) Clears Natural Cycles As The First Digital Method Of Birth Control In The United States

Natural Cycles today announced that its application for De Novo classification as a Class II medical device has been granted by the United States...


Aug 13, 2018, 09:05 ETIvantis Announces FDA Approval for Its Innovative Hydrus® Microstent Device for Minimally Invasive Glaucoma Surgery (MIGS)

Ivantis, a company dedicated to developing new and innovative solutions for glaucoma, announced today that it received Food and Drug Administration...


Aug 13, 2018, 08:45 ET7D Surgical Receives FDA Approval For Cranial Surgery

7D Surgical announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Cranial Module. This...


Aug 10, 2018, 16:49 ETFDA approves new treatment for a rare genetic disorder, Fabry disease

The U.S. Food and Drug Administration today approved Galafold (migalastat), the first oral medication for the treatment of adults with Fabry disease. ...


Aug 10, 2018, 15:22 ETFDA Approves the First One-Year Contraceptive Fully under a Woman's Control

The Population Council, a global nonprofit research organization, announced it has received U.S. Food and Drug Administration (FDA) approval for...


Aug 10, 2018, 14:12 ETFDA approves new vaginal ring for one year of birth control

The U.S. Food and Drug Administration today approved Annovera (segesterone acetate and ethinyl estradiol vaginal system), which is a combined...


Aug 10, 2018, 13:44 ETFDA approves first-of-its kind targeted RNA-based therapy to treat a rare disease

The U.S. Food and Drug Administration today approved Onpattro (patisiran) infusion for the treatment of peripheral nerve disease (polyneuropathy)...


Aug 10, 2018, 13:17 ETFDA allows marketing of first direct-to-consumer app for contraceptive use to prevent pregnancy

The U.S. Food and Drug Administration today permitted marketing of the first mobile medical application (app) that can be used as a method of...


Aug 09, 2018, 09:49 ETUS Food and Drug Administration Approves ARAKODA™ (tafenoquine) tablets for oral use; First preventative antimalarial approved in almost two decades

60 Degrees Pharmaceuticals (60P) announced today the U.S. Food and Drug Administration (FDA) approval of ARAKODA™ (tafenoquine) tablets for the...


Aug 09, 2018, 09:04 ETSom Sleep Is Officially Non-GMO Project Verified

Som Sleep announces its ready-to-drink sleep supplements, Som Sleep Original and Som Sleep Zero Sugar, are officially Non-GMO Project Verified. "We...