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 26, 2016, 13:04 ET Sight Sciences Receives Full Investigational Device Exemption (IDE) Approval from the US FDA to Initiate the VISCO™360 versus SLT Glaucoma Trial

Sight Sciences, Inc., a venture-backed, commercial-stage ophthalmic medical device company announced today that it has received full IDE approval...


Jul 26, 2016, 10:00 ET LSK BioPharma Announces Successful Outcome from End-of-Phase 2 meeting with FDA

LSK BioPharma (LSKB) today announced the successful completion and positive outcome of an End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug...


Jul 26, 2016, 08:35 ET Registrar Corp Launches FSMA Wizard: Identify Your Requirements Under FDA's New Rules

 On July 25, 2016, FDA regulatory compliance firm Registrar Corp launched the FSMA Compliance Wizard, a free tool to help food facilities,...


Jul 26, 2016, 08:30 ET Instrumentation Laboratory Receives US FDA Clearance For New HemosIL® HIT-Ab(PF4-H) Assay

 Instrumentation Laboratory (IL) today announced the 510(k) clearance of the HemosIL HIT-Ab(PF4-H) assay for use on ACL...


Jul 25, 2016, 20:56 ET Daratumumab (DARZALEX®) Granted Breakthrough Therapy Designation by U.S. Food and Drug Administration (FDA) for Use in Combination with Standard of Care Regimens for Patients with Multiple Myeloma

 The U.S. Food and Drug Administration (FDA) has granted a Breakthrough Therapy Designation to the immunotherapy daratumumab (DARZALEX®)...


Jul 25, 2016, 17:04 ET AbbVie Receives U.S. FDA Approval of Once-Daily VIEKIRA XR™ (dasabuvir, ombitasvir, paritaprevir and ritonavir) for the Treatment of Genotype 1 Chronic Hepatitis C

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


Jul 25, 2016, 09:00 ET Syneron Candela's PicoWay Picosecond Laser Receives U.S. FDA Clearance for Ultra-Short 785nm Wavelength

 Syneron Medical Ltd. (NASDAQ:ELOS), a leading global aesthetic device company, announced today that the PicoWay® picosecond laser...


Jul 22, 2016, 06:05 ET FDA Advisory Committee Votes in Favor of Non-Adjunctive Label for DexCom G5 Mobile CGM System

 DexCom, Inc. (NASDAQ:DXCM), the leader in continuous glucose monitoring (CGM) for patients with diabetes, announced today that the Clinical...


Jul 22, 2016, 02:00 ET Valeant Pharmaceuticals Receives Complete Response Letter From The FDA

No Safety or Efficacy Concerns or Additional Clinical Trials Identified for Approval of Latanoprostene Bunod FDA Letter Related to CGMP at Bausch...


Jul 21, 2016, 08:00 ET Relievant Medsystems, Inc. Receives FDA 510(k) Clearance for INTRACEPT® for the Relief of Chronic Low Back Pain

Relievant Medsystems, Inc., a privately held medical device company pioneering the therapy of nerve ablation within vertebral bodies for the...


Jul 21, 2016, 07:00 ET LifeBond Receives FDA IDE Approval for LifeSeal GI Surgical Sealant Clinical Trial

LifeBond, a leader in the development of bio-surgical medical devices for tissue repair, announced today that it has received a U.S. Food and...


Jul 21, 2016, 06:11 ET Vasorum Ltd. reçoit l'approbation de la FDA pour son obturateur vasculaire Celt ACD®

Le développeur et fabricant du nouvel obturateur vasculaire Celt ACD® a reçu l'approbation de sa demande d'autorisation de...


Jul 21, 2016, 06:10 ET Vasorum Ltd. recibe la aprobación de la FDA para el dispositivo de cierre vascular Celt ACD®

El desarrollador y fabricante del nuevo dispositivo de cierre vascular Celt ACD® ha recibido la aprobación de su solicitud PMA desde la...


Jul 21, 2016, 06:09 ET Vasorum Ltd. erhält FDA-Zulassung für das Gefäßversiegelungsgerät Celt ACD®

Der Entwickler und Hersteller des neuartigen Gefäßversiegelungsgeräts Celt ACD® erhielt auf seinen Antrags auf Erteilung...


Jul 21, 2016, 06:06 ET Vasorum Ltd. Receives FDA Approval for Celt ACD® Vascular Closure Device

Vasorum Ltd. The developer and manufacturer of the novel Celt ACD® vascular closure device has received approval of its PMA application from...


Jul 21, 2016, 02:00 ET Cydar EV Gains FDA Clearance for Revolutionary 3D Surgical Guidance Software

- FDA Clears Cloud-based 'Sat Nav for Surgeons' Software for Sale in the US  - Cydar EV Uses High Performance Cloud Computing to Provide...


Jul 20, 2016, 11:30 ET Inova Diagnostics receives FDA clearance for QUANTA Flash dsDNA, QUANTA Flash Jo-1, and QUANTA Flash Scl-70

 Inova Diagnostics, a worldwide leader in autoimmune diagnostic reagents and systems for the clinical...


Jul 20, 2016, 11:03 ET Mylan Launches Generic Crestor® Tablets

 Mylan N.V. (NASDAQ, TASE: MYL) today announced the U.S. launch of Rosuvastatin Calcium Tablets, 5 mg, 10 mg, 20 mg and 40 mg, which is a...


Jul 20, 2016, 08:25 ET Viracor-IBT Laboratories, Inc.'s Zika Virus RT-PCR Test Receives Emergency Use Authorization From the FDA

Viracor-IBT Laboratories, Inc. (Viracor-IBT), a wholly-owned subsidiary of Eurofins Scientific (EUFI.PA), today announced that it received...


Jul 20, 2016, 06:57 ET Lannett Announces Receipt Of FDA Acceptable Filing Letter For Fentanyl Patch ANDA

Lannett Company, Inc. (NYSE: LCI) today announced that its strategic partner, Sparsha Pharma USA, Inc., has received an Acceptable for Filing...


Jul 19, 2016, 18:04 ET Valeant and Progenics Announce FDA Approves RELISTOR® Tablets for the Treatment of Opioid-Induced Constipation in Adults with Chronic Non-cancer Pain

Valeant Pharmaceuticals International, Inc. (NYSE & TSX: VRX) and Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) today announced that the U.S....


Jul 19, 2016, 08:26 ET Eisai Inc. and Arena Pharmaceuticals Announce FDA Approval of BELVIQ XR® (lorcaserin HCl) Extended-Release Tablets

 Eisai Inc. and Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) today announced that the U.S. Food and Drug Administration (FDA) has approved the...


Jul 19, 2016, 08:00 ET U.S. FDA expands indication for type 2 diabetes treatment Synjardy® (empagliflozin/metformin hydrochloride) to include treatment-naïve adults

The U.S. Food and Drug Administration has approved an expanded indication for Synjardy® (empagliflozin and metformin hydrochloride) tablets to...


Jul 19, 2016, 07:59 ET Allergan and Adamas Announce New Expanded Indication for NAMZARIC® (Memantine and Donepezil Hydrochlorides) Extended Release for the Treatment of Moderate to Severe Alzheimer's Disease

Allergan plc (NYSE: AGN) and Adamas Pharmaceuticals, Inc. (NASDAQ: ADMS), today announced that the U.S. Food and Drug Administration (FDA) has...


Jul 18, 2016, 11:55 ET U.S. FDA Approves CSL Behring's Berinert® as the First and Only Pediatric Treatment for Hereditary Angioedema (HAE)

 CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has approved the use of Berinert [C1 Esterase Inhibitor (Human)],...