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

14:46 ET FDA approves first telehealth option to program cochlear implants remotely

The U.S. Food and Drug Administration today approved a remote feature for follow-up programming sessions for the Nucleus Cochlear Implant System...


08:58 ET Insulia recibe la autorización de la FDA y el marcado CE para integrar Basaglar y Tresiba

Insulia ya está autorizada a realizar la titulación de todas las marcas de insulina basal Voluntis ha anunciado hoy que Insulia®, su solución...


08:48 ET Insulia erhält die FDA-Zulassung und CE-Kennzeichnung für die Integration von Basaglar und Tresiba

Insulia ist damit für die Titration aller Marken von Basalinsulin zugelassen Voluntis gab heute bekannt, dass Insulia®, sein digitaler...


08:39 ET Insulia a reçu l'agrément de la FDA et le marquage CE en vue d'intégrer le Basaglar et le Tresiba

Insulia détient désormais un agrément pour le titrage de toutes les marques d'insuline basale Aujourdhui, Voluntis a annoncé qu'Insulia®, son...


Nov 16, 2017, 16:02 ET FDA expands approval of Sutent to reduce the risk of kidney cancer returning

The U.S. Food and Drug Administration today approved Sutent (sunitinib malate) for the adjuvant treatment of adult patients who are at a high risk...


Nov 16, 2017, 14:21 ET Mitsubishi Tanabe Pharma America Announces 1,000 People with ALS Have Received FDA-Approved Treatment Option in First Three Months Available

Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced that more than 1,000 people with amyotrophic lateral sclerosis (ALS) have been...


Nov 16, 2017, 08:45 ET Vermillion Announces Publication of Foundational Health Economics Study

Vermillion (NASDAQ: VRML) announced today the acceptance and publication of a novel paper, "Economic Impact of Increased Utilization of...


Nov 16, 2017, 08:00 ET Insulia receives FDA clearance and CE mark to integrate Basaglar and Tresiba

Today, Voluntis announced that Insulia®, its digital companion for people with Type 2 diabetes, has received FDA clearance and the CE mark to...


Nov 16, 2017, 08:00 ET U.S. FDA issues GRAS No Objection Letter for BESTEVIA® Reb D Stevia Leaf Sweetener

SweeGen, Inc., a nature-based sweetener company, and Ingredion Incorporated, a leading global provider of ingredient solutions to diversified...


Nov 16, 2017, 07:15 ET TSO3 Provides Duodenoscope Regulatory Filing Update

QUEBEC CITY and MYRTLE BEACH, SC, Nov. 16, 2017 /PRNewswire/ - TSO3 Inc. (TSX: TOS), an innovator in sterilization technology for medical devices...


Nov 15, 2017, 21:36 ET Ascentage Pharma Announces U.S. FDA Acceptance of IND Application for Clinical Study of Novel IAP Inhibitor APG-1387 to Treat Advanced Solid Tumors and Blood Cancers

Ascentage Pharma, a global clinical-stage biopharmaceutical company dedicated to developing apoptosis-targeted therapies, today announced that the...


Nov 15, 2017, 12:08 ET FDA approves treatment for rare genetic enzyme disorder

The U.S. Food and Drug Administration today approved Mepsevii (vestronidase alfa-vjbk) to treat pediatric and adult patients with an inherited...


Nov 15, 2017, 11:31 ET FDA grants marketing authorization of the first device for use in helping to reduce the symptoms of opioid withdrawal

Today, the U.S. Food and Drug Administration granted a new indication to an electric stimulation device for use in helping to reduce the symptoms...


Nov 15, 2017, 10:36 ET Noden Pharma Announces FDA Approval of Tekturna®(aliskiren) Oral Pellets for the Treatment of Hypertension in Adults and Children 6 Years of Age and Older

Noden Pharma DAC, a global specialty pharmaceutical company that is focused on acquiring prescription medicines across a broad range of therapeutic...


Nov 15, 2017, 08:00 ET Alcyone Lifesciences Receives FDA Clearance for the Alivio System for the Treatment of Hydrocephalus

Alcyone Lifesciences, Inc., announced that the U.S. Food and Drug Administration (FDA) cleared the Alivio Ventricular Catheter & Flusher System...


Nov 14, 2017, 19:02 ET FASENRA (benralizumab) Receives US FDA Approval For Severe Eosinophilic Asthma

AstraZeneca (NYSE: AZN) and its global biologics research and development arm, MedImmune, today announced that the US Food and Drug Administration...


Nov 14, 2017, 13:00 ET Roche receives FDA clearance for the VENTANA MMR IHC Panel for patients diagnosed with colorectal cancer

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced US Food & Drug Administration (FDA) clearance of the VENTANA MMR IHC Panel, which provides...


Nov 14, 2017, 07:50 ET MedShape Announces FDA Clearance for the DynaNail® XL

MedShape, Inc., the industry leader in orthopaedic devices using advanced functional materials, announced today that the company has received U.S....


Nov 14, 2017, 00:16 ET Otsuka And Proteus® Announce The First U.S. FDA Approval Of A Digital Medicine System: ABILIFY MYCITE® (aripiprazole tablets with sensor)

Otsuka Pharmaceutical Co., Ltd. (Otsuka) and Proteus Digital Health (Proteus) today announce that the United States Food and Drug Administration...


Nov 13, 2017, 19:17 ET FDA approves pill with sensor that digitally tracks if patients have ingested their medication

The U.S. Food and Drug Administration today approved the first drug in the U.S. with a digital ingestion tracking system. Abilify MyCite...


Nov 13, 2017, 08:00 ET EMD Serono Receives FDA Approval for New GONAL-f® RFF Redi-ject® Pen

EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, received approval for a redesigned version of...


Nov 13, 2017, 07:35 ET Allergan Receives FDA Approval For Use of VRAYLAR™ (cariprazine) in the Maintenance Treatment of Schizophrenia

Allergan plc (NYSE: AGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA)...


Nov 09, 2017, 09:00 ET Northwestern Medicine offers new Minimally Invasive Breakthrough Treatment for Enlarged Prostate

Northwestern Medicine's urology department is excited to announce a minimally invasive treatment option for men with enlarged prostates. The...


Nov 09, 2017, 08:30 ET Stryker receives US FDA HDE approval for the Neuroform Atlas™ Stent System to treat wide neck aneurysms

Stryker Corporation announced today that the U.S. Food and Drug Administration has approved the Neuroform Atlas™ Stent System for marketing under a...


Nov 08, 2017, 17:34 ET DT MedTech Announces 510(k) FDA Clearance for Hintermann Series H2™ Total Ankle Replacement System

DT MedTech, LLC (DTM) today announced that the Hintermann Series H2™ Total Ankle Replacement System has received 510(k) clearance from the U.S....