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

Feb 15, 2017, 08:00 ET The FDA has Approved Tirosint-SOL, Levothyroxine in Liquid Solution for the American Market, IBSA Patent

IBSA announced today that the US Food and Drug Administration (FDA) has approved Tirosint-SOL (levothyroxine sodium oral solution), a liquid...


Feb 15, 2017, 07:00 ET Cepheid Announces FDA Clearance Of Xpert® Xpress Flu And Xpert Xpress Flu/RSV

Cepheid today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to market Xpert® Xpress Flu and Xpert...


Feb 15, 2017, 06:00 ET L'FDA ha Approvato per il Mercato Americano Tirosint-SOL, Levotiroxina, Formulazione Liquida, Brevetto IBSA

Studi Clinici hanno Dimostrato che Tirosint-SOL è in Grado di Superare Alcuni Limiti Delle Compresse di Levotiroxina IBSA annuncia oggi che US...


Feb 15, 2017, 02:00 ET La FDA a approuvé Tirosint-SOL (lévothyroxine en solution liquide) pour le marché américain, avec un brevet IBSA

Des études cliniques ont démontré que Tirosint-SOL peut vaincre certaines des limites inhérentes aux comprimés de lévothyroxine IBSA a...


Feb 15, 2017, 02:00 ET La FDA ha aprobado Tirosint-SOL, levotiroxina en solución líquida para el mercado americano, patente IBSA

Estudios clínicos han demostrado que Tirosint-sol podría superar algunas de las limitaciones de las tabletas de levotiroxina IBSA anunció...


Feb 15, 2017, 02:00 ET FDA genehmigt Tirosint-SOL, Levothyroxin in flüssiger Lösung, für den amerikanischen Markt - Patent von IBSA

Klinische Studien haben gezeigt, dass Tirosint-SOL einige der Einschränkungen von Levothyroxin-Tabletten überwinden IBSA hat heute...


Feb 13, 2017, 09:08 ET XTL Biopharmaceuticals Expands Clinical Advisory Board to Support Phase II Study of HCDR1 in Sjogren's Syndrome

- Dr. Robert I. Fox and Professor Simon Bowman are world-renowned rheumatologists and experts in Sjogren's syndrome - XTL...


Feb 13, 2017, 09:02 ET National Institutes of Health Funds Schneider Children's Medical Center and International Diabetes Center Closed-Loop System Research

The Institute for Endocrinology and Diabetes at Schneider Children's Medical Center in Petah Tikva, Israel, along with the International Diabetes...


Feb 09, 2017, 17:55 ET MDA Celebrates News of FDA Approval of Emflaza for Treatment of Duchenne Muscular Dystrophy

The Muscular Dystrophy Association today welcomed news of the U.S. Food and Drug Administration's decision to grant approval for deflazacort (brand...


Feb 09, 2017, 13:54 ET FDA approves drug to treat Duchenne muscular dystrophy

The U.S. Food and Drug Administration today approved Emflaza (deflazacort) tablets and oral suspension to treat patients age 5 years and older with...


Feb 09, 2017, 08:00 ET Access Scientific Announces FDA Clearance for New 3 French, 6 cm POWERWAND to Eliminate Repetitive Needlesticks for IV Access

Access Scientific, LLC, announced today the FDA clearance of its new 3 French, 6cm POWERWAND™-- the first true Extended-Dwell Intravenous Catheter...


Feb 08, 2017, 06:45 ET Lilly's Trulicity® (dulaglutide) Label Updated to Include Use in Combination with Basal Insulin for Adults with Type 2 Diabetes

The label for Eli Lilly and Company's (NYSE: LLY) once-weekly Trulicity® (dulaglutide) is now updated to include use in combination with basal...


Feb 07, 2017, 18:13 ET FDA Approves Amgen's Parsabiv™ (Etelcalcetide), First New Treatment In More Than A Decade For Secondary Hyperparathyroidism In Adult Patients On Hemodialysis

Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved Parsabiv™ (etelcalcetide) for the treatment of...


Feb 07, 2017, 10:30 ET FDA Approves Bio Products Laboratory's Gammaplex® 10% for Treatment of Primary Immunodeficiency and Chronic Immune Thrombocytopenic Purpura

Bio Products Laboratory Limited (BPL), a leading manufacturer of plasma-derived protein therapies, today announced that the U.S. Food and Drug...


Feb 07, 2017, 08:30 ET Bioness Receives FDA Clearance for the L300 Go™ System

Bioness, Inc., the leading provider of cutting-edge, clinically supported rehabilitation therapies, today announced that it received clearance from...


Feb 07, 2017, 08:00 ET Emmaus Life Sciences, Inc. Receives Notice of Allowance for Japanese Patent for use of L-glutamine in Treatment of Diabetes

Emmaus announced today the allowance of patent application number 2014-542296, by the Japanese Patent Office for the use of its lead investigative...


Feb 06, 2017, 18:39 ET First automated ANCA IFA assays cleared by FDA

Inova Diagnostics, a worldwide leader in autoimmune diagnostic reagents and systems for the clinical laboratory, announced today that the United...


Feb 06, 2017, 12:30 ET Baebies Receives FDA de novo Clearance for First Lysosomal Storage Disease Newborn Screening Platform, SEEKER™

Baebies, a company focused on advancing newborn screening and pediatric testing, announced today it has received de novo clearance from the U.S....


Feb 06, 2017, 09:00 ET Kindred Biosciences Receives Early Approval of Effectiveness Technical Section from FDA for Mirataz™ New Animal Drug Application

Kindred Biosciences, Inc. (NASDAQ: KIN), a biopharmaceutical company focused on saving and improving the lives of pets, today announced it has...


Feb 03, 2017, 17:41 ET Intarcia Announces FDA Filing Acceptance of New Drug Application (NDA) for ITCA 650 for the Treatment of Type 2 Diabetes

Intarcia Therapeutics, Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted for active review its New Drug...


Feb 02, 2017, 08:00 ET U.S. FDA Grants Abbott the First Commercial Authorization for a Molecular Test to Detect Zika Virus Using Whole Blood

Abbott (NYSE: ABT) announced today that the U.S. Food and Drug Administration (FDA) has authorized its molecular test, the Abbott RealTime ZIKA...


Feb 02, 2017, 08:00 ET U.S. FDA Grants Priority Review to AbbVie for its Investigational Regimen of Glecaprevir/Pibrentasvir (G/P) for the Treatment of Chronic Hepatitis C in All Major Genotypes (GT1-6)

AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug...


Feb 01, 2017, 16:30 ET Zimmer Biomet Announces FDA Approval of Expanded 26-week Efficacy Claim for Gel-One® Cross-Linked Hyaluronate for Treatment of Pain Associated with Knee Osteoarthritis

Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced that the U.S. Food and Drug...


Feb 01, 2017, 09:15 ET New Studies on Hazardous Drug Delivery Confirm Equashield to be Truly Closed System, as Defined by NIOSH

Equashield, a leading provider of Closed System Transfer Devices (CSTDs) for the safe and simple handling of hazardous drugs, today announced the...


Feb 01, 2017, 08:38 ET Kitov Granted Notice of Allowance from U.S. Patent & Trademark Office for KIT-302

Patent Further Strengthens Company's IP position ahead of Planned New Drug Application to be Submitted to FDA Kitov Pharmaceuticals Holdings Ltd....