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 28, 2017, 08:48 ET FDA Licenses ORTHO™ Sera designed for Extended Phenotype Testing for Use with Ortho ID-MTS™ Gel Card Technology

Ortho Clinical Diagnostics (Ortho), a global leader of in vitro diagnostics, today announced that ORTHO™ Sera blood grouping reagents designed for...


Aug 28, 2017, 02:09 ET Lumosa Therapeutics Partners with Camargo Pharmaceutical Services in the Development of Naldebain(R) in the US

Lumosa Therapeutics Co., Ltd. ("Lumosa"), a Taipei-based biopharmaceutical company developing innovative therapies focused on the treatment of...


Aug 25, 2017, 12:18 ET Victoza® (liraglutide) is approved in the US as the only type 2 diabetes treatment indicated to reduce the risk of three major adverse cardiovascular events

The U.S. Food and Drug Administration (FDA) has approved a new indication for Victoza® (liraglutide) to reduce the risk of major adverse...


Aug 24, 2017, 07:00 ET Titan Pharmaceuticals Receives FDA Clearance To Begin Clinical Study Of Parkinson's Disease Treatment

Titan Pharmaceuticals, Inc. (NASDAQ: TTNP) announced today that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New...


Aug 23, 2017, 08:00 ET Epygenix Therapeutics Receives US FDA Orphan Drug Designation for EPX-300 for the Treatment of Patients With Dravet Syndrome

Epygenix Therapeutics, Inc., a privately held biopharmaceutical company developing precision medicine for rare and catastrophic forms of genetic...


Aug 22, 2017, 08:45 ET Jupiter Orphan Therapeutics Receives Orphan Drug Designation for its Trans-Resveratrol Product JOTROL for Treatment of Friedreich's Ataxia

Jupiter Orphan Therapeutics, Inc. ("JOT"), Jupiter, FL, today announced that it has received notification from the US Food and Drug Administration...


Aug 21, 2017, 16:05 ET QIAGEN and Clinical Genomics Partner on Liquid Biopsies to Monitor Patients for Recurrence of Colorectal Cancer

QIAGEN (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) and Clinical Genomics, a private company developing evidence-based diagnostic tools for...


Aug 21, 2017, 10:03 ET BIOTRONIK US Launches Smallest MR Conditional Quadripolar Cardiac Resynchronization Therapy Pacemaker

BIOTRONIK today announced FDA approval and commercial availability of Edora HF-T QP, an MR conditional quadripolar (QP) cardiac resynchronization...


Aug 21, 2017, 09:00 ET Perrigo Announces Final FDA Approval And Settlement For The Store Brand OTC Equivalent Of Nexium® 24HR Capsules

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


Aug 17, 2017, 18:41 ET Prollenium Medical Technologies Inc. announces U.S. FDA approval for its cross-linked hyaluronic acid dermal filler

AURORA, ON, Aug. 17, 2017 /PRNewswire/ - Prollenium Medical Technologies Inc., a leading medical device manufacturer, announced today its United...


Aug 17, 2017, 15:51 ET FDA provides new tools for the development and proper evaluation of tests for detecting Zika virus infection

As an additional measure in the fight against Zika virus, today the U.S. Food and Drug Administration announced that it has made available a panel...


Aug 17, 2017, 13:54 ET FDA approves new treatment for adults with relapsed or refractory acute lymphoblastic leukemia

The U.S. Food and Drug Administration today approved Besponsa (inotuzumab ozogamicin) for the treatment of adults with relapsed or refractory...


Aug 16, 2017, 12:08 ET US FDA grants Lion TCR two orphan drug designations of T cell therapy against Hepatocellular Carcinoma

US FDA has granted two orphan drug designations (ODD) for T cell therapy products to Singapore-based biotech company, Lion TCR Pte Ltd, for the...


Aug 16, 2017, 08:51 ET Perrigo Announces FDA Final Approval for its AB Rated Generic Version of Mycolog® II Cream

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...


Aug 16, 2017, 02:51 ET FDA Accepts Medivir´s IND Application for MIV-711, Enabling Clinical Development in the US

Medivir AB (Nasdaq Stockholm: MVIR) announces today that the Investigational New Drug (IND) application for MIV-711 has been accepted and the IND...


Aug 15, 2017, 08:08 ET Camber Spine Technologies Announces FDA Clearance And National Launch Of SPIRA™ Open Matrix ALIF

Camber Spine Technologies announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its...


Aug 11, 2017, 16:31 ET FDA warns of potential contamination in multiple brands of drugs, dietary supplements

The U.S. Food and Drug Administration is advising consumers and health care professionals not to use any liquid drug or dietary supplement products...


Aug 11, 2017, 09:30 ET Renovis® Surgical Receives FDA Clearance for 3D-Printed Posterior Lumbar Interbody Fusion Systems

Renovis Surgical Technologies, Inc. announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to...


Aug 11, 2017, 07:00 ET Ionis to Independently Advance Inotersen and IONIS-FB-L Rx

Ionis Pharmaceuticals, Inc. (NASDAQ: IONS) today reported that the Company has retained all rights to inotersen and IONIS-FB-LRx. As part...


Aug 09, 2017, 11:02 ET InDex Pharmaceuticals Receives Orphan-drug Designation for Pediatric Ulcerative Colitis in the US

InDex Pharmaceuticals Holding AB (publ) today announced that the US Food and Drug Administration (FDA) has granted orphan-drug designation for the...


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