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

Nov 21, 2017, 14:01 ET FDA approves first two-drug regimen for certain patients with HIV

The U.S. Food and Drug Administration today approved Juluca, the first complete treatment regimen containing only two drugs to treat certain adults...


Nov 21, 2017, 11:37 ET Janssen Submits Application to U.S. FDA to Expand Indication for DARZALEX® (daratumumab) Combination Therapy for Patients with Newly Diagnosed Multiple Myeloma who are Transplant Ineligible

Janssen Biotech, Inc. today announced that it has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug...


Nov 21, 2017, 08:05 ET U.S. FDA Accepts Regulatory Submission and Grants Priority Review for US WorldMeds' Lofexidine

US WorldMeds today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review of the New Drug Application...


Nov 20, 2017, 08:01 ET U.S. FDA Approves Kaléo's AUVI-Q® (Epinephrine Injection, USP) 0.1 mg Auto-Injector for Life-Threatening Allergic Reactions in Infants and Small Children

kaléo, a privately-held pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental New...


Nov 20, 2017, 08:00 ET Volpara Receives Regulatory Clearances in Japan and Taiwan

Volpara Solutions announced today that it has received regulatory clearances for its suite of quantitative breast imaging tools in Japan and...


Nov 17, 2017, 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...


Nov 17, 2017, 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...


Nov 17, 2017, 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...


Nov 17, 2017, 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 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, 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, 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...