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

16 May, 2017, 07:30 ET Sangamo Receives Fast Track Designation From The FDA For SB-525 Investigational Hemophilia A Gene Therapy

Sangamo Therapeutics, Inc. (NASDAQ: SGMO) announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to...


16 May, 2017, 06:52 ET Lannett Announces Approval For Levocetirizine Dihydrochloride Oral Solution, 2.5 mg/5 mL (0.5 mg/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...


15 May, 2017, 12:09 ET Resverlogix recibe aprobación de la FDA para un ensayo clínico de Apabetalone

- Resverlogix recibe la aprobación de la División Cardiovascular y Renal de la FDA para proceder a un ensayo clínico solicitado de Apabetalone...


15 May, 2017, 12:02 ET Body Vision Medical Receives FDA Clearance for the LungVision Navigation System, Revolutionizing the Areas of Lung Cancer Detection and Treatment

Body Vision Medical, a medical device company specializing in augmented real-time imaging, announced today that it has received clearance from the...


15 May, 2017, 09:35 ET Resverlogix Receives Approval From The FDA Cardiovascular and Renal Division To Proceed With A Requested Apabetalone Clinical Trial

Apabetalone expands to a second major clinical indication in kidney dialysis patients CALGARY, May 15, 2017 /PRNewswire/ - Resverlogix Corp....


15 May, 2017, 08:00 ET Glenmark Pharmaceuticals to Initiate Clinical Study for GBR 1342, Second Investigational New Drug from Immuno-Oncology Portfolio

Glenmark Pharmaceuticals, a global pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) cleared the company's...


15 May, 2017, 07:36 ET Nuvo Pharmaceuticals™ Inc. Announces Topline Results from European Ankle Sprain Study with Pennsaid® 2%

- Pennsaid 2% Already Approved for Marketing in the United States and Russia - MISSISSAUGA, ON, May 15, 2017 /PRNewswire/ - Nuvo Pharmaceuticals...


12 May, 2017, 12:54 ET FDA authorizes use of new device to treat esophageal birth defect in babies

The U.S. Food and Drug Administration today authorized use of the Flourish Pediatric Esophageal Atresia Anastomosis, a first-of-its-kind medical...


11 May, 2017, 08:47 ET La pantalla expositora con batería de ZeroWire Mobile de NDS autorizada por la FDA

NDS ha anunciado hoy que ha recibido la autorización 510(k) de la Administración de Alimentos y Medicamentos estadounidense (FDA en sus siglas en...


11 May, 2017, 08:00 ET Xencor's Lead Drug Candidate, XmAb5871, Receives Orphan Drug Designation from FDA for Treatment of IgG4-Related Disease

Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of autoimmune...


11 May, 2017, 07:00 ET SYN-004 (Ribaxamase) Receives Breakthrough Therapy Designation from U.S. Food and Drug Administration for Prevention of Clostridium difficile Infection

Synthetic Biologics, Inc. (NYSE MKT: SYN), a late-stage clinical company developing therapeutics that preserve the microbiome to protect and...


11 May, 2017, 06:00 ET NDS receives FDA clearance for ZeroWire Mobile battery-powered display stand

NDS today announced it has received FDA 510(k) clearance for its new ZeroWire® Mobile battery-powered display stand solution. Designed to enable...


11 May, 2017, 06:00 ET NDS erhält FDA-Zulassung für batteriebetriebenen Präsentationsständer ZeroWire Mobile

NDS kündigte heute, die FDA 510(k)-Zulassung für seine neue batteriebetriebene Präsentationsständer-Lösung ZeroWire®Mobile erhalten zu haben....


11 May, 2017, 06:00 ET NDS reçoit l'autorisation du FDA pour son socle d'écran ZeroWire Mobile alimenté par batterie

SAN JOSÉ, Californie, 11 mai 2017 /PRNewswire/-- NDS a annoncé aujourd'hui avoir reçu la notification préalable à la commercialisation 510(k) du...


11 May, 2017, 03:01 ET Leica Biosystems Applauds FDA Primary Diagnosis Clearance as a Step Forward in Clinical Acceptance of Digital Pathology

The digital pathology industry just took another step forward, with the FDA clearance of a whole slide imaging (WSI) system (Philips IntelliSite™...


10 May, 2017, 12:44 ET NxStage Medical Announces FDA Clearance for its New System One Hemodialysis System

NxStage Medical, Inc. (NASDAQ: NXTM), a leading medical technology company focused on advancing renal care, today announced that its next...


10 May, 2017, 08:00 ET Bridge Therapeutics to Present at BioTrinity 2017 Conference in London

Bridge Therapeutics, Inc., an innovative development-stage specialty pharmaceutical company, has announced that its CEO and Chief Scientific...


10 May, 2017, 05:46 ET Adimmune's Quadrivalent Flu Vaccine Approved by TFDA

Taiwan-based vaccine provider Adimmune (4142.TT) successfully obtained approval of its quadrivalent flu vaccine (ADIMFLU-S(QIS)) from Taiwan...


09 May, 2017, 15:53 ET FDA Grants BAVENCIO® (avelumab) Approval for a Common Type of Advanced Bladder Cancer

EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the US and Canada, and Pfizer Inc. (NYSE: PFE) today announced...


09 May, 2017, 09:00 ET INSIGHTEC Receives FDA Approval for Exablate Neuro for 1.5T MRI in the Treatment of Essential Tremor

INSIGHTEC, the leader in MR-guided Focused Ultrasound (MRgFUS), announced today that the FDA has approved its Exablate Neuro (Model 4000) system...


09 May, 2017, 07:00 ET Biscayne Readies Phase 1b Trial for Novel Antiepileptic Agent BIS-001 and Receives FDA Orphan Drug Designation for Dravet Syndrome

Biscayne Neurotherapeutics, Inc., a clinical-stage company developing novel treatments for neurological disorders, today announced that lead...


09 May, 2017, 06:30 ET Boston Scientific Receives U.S. FDA Approval For Resonate™ Family Of High-Voltage Devices

Boston Scientific (NYSE: BSX) has received U.S. Food and Drug Administration (FDA) approval for the Resonate™ family of implantable cardioverter...


08 May, 2017, 18:47 ET Bausch + Lomb Announces PDUFA Date For New OTC Redness Reliever, Brimonidine Tartrate Ophthalmic Solution, 0.025%

PDUFA date set for December 27, 2017 Valeant Pharmaceuticals International, Inc.'s (NYSE: VRX and TSX: VRX) wholly owned subsidiary, Bausch +...


08 May, 2017, 16:15 ET Novartis receives FDA approval for first-of-its-kind Kisqali® Femara® Co-Pack for initial treatment of HR+/HER2- advanced or metastatic breast cancer

Novartis announced today that the US Food and Drug Administration (FDA) has approved the Kisqali® Femara® Co-Pack (ribociclib tablets; letrozole...


08 May, 2017, 13:55 ET BIOTRONIK Announces FDA Approval of MultiPole Pacing with ProMRI: 360° Solutions for Patients with Heart Failure

BIOTRONIK today announced FDA approval of the company's MultiPole Pacing (MPP) technology, providing physicians with additional treatment options...