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 28, 2016, 08:12 ET FDA approves Adlyxin to treat type 2 diabetes

The U.S. Food and Drug Administration approved Adlyxin (lixisenatide), a once-daily injection to improve glycemic control (blood sugar levels),...


Jul 28, 2016, 08:00 ET Smith & Nephew's NAVIO™ Surgical System achieves robotics-assisted milestone for total knee replacement surgery

Smith & Nephew (NYSE:SNN; LSE:SN), the global medical technology business, today announces the first surgical case of its robotics-assisted...


Jul 28, 2016, 08:00 ET FDA Clears Expanded Indication for Itamar Medical's WatchPAT™ Sleep Apnea Diagnostic Device for Adolescents

Itamar Medical (TASE:ITMR), which develops and markets non-invasive diagnostic medical devices for sleep-related breathing disorders, received FDA...


Jul 27, 2016, 20:12 ET Sanofi Receives FDA Approval of Adlyxin™ for Treatment of Adults with Type 2 Diabetes

Sanofi announced today that the U.S. Food and Drug Administration (FDA) approved Adlyxin™ (lixisenatide), a once-daily mealtime GLP-1...


Jul 27, 2016, 16:10 ET Regulus Provides Update on Clinical Hold of RG-101

 Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company leading the discovery and development of innovative medicines...


Jul 27, 2016, 13:42 ET Companion Medical Receives FDA Clearance for Smart Insulin Delivery System

Companion Medical, a leader in the development of advanced technology to improve diabetes care, announced today that the U.S. Food and Drug...


Jul 27, 2016, 13:05 ET 4WEB Medical Announces FDA Clearance of Lateral Spine Truss System

4WEB Medical, the industry leader in 3D printed orthopedic implants, announced today that the company has received 510K clearance from the FDA for...


Jul 27, 2016, 10:00 ET CSL Behring Presents Pivotal Efficacy Data for AFSTYLA® In Adolescents and Children with Hemophilia A at the World Federation of Hemophilia 2016 World Congress

 CSL Behring today presented data from a Phase III pivotal study of AFSTYLA® [Antihemophilic Factor (Recombinant), Single Chain]...


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...