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

02 May, 2017, 07:00 ET BioDelivery Sciences Announces the Approval of BUNAVAIL® for Induction of Buprenorphine Treatment for Opioid Dependence

BioDelivery Sciences International, Inc. (NASDAQ: BDSI) announced that the U.S. Food and Drug Administration (FDA) has approved a Supplemental New...


01 May, 2017, 15:52 ET AstraZeneca's IMFINZI™ (Durvalumab) Receives US FDA Accelerated Approval For Previously Treated Patients With Advanced Bladder Cancer

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


01 May, 2017, 10:00 ET FDA clears Roche high-volume immunoassay lab testing solution to support critical medical treatment decisions

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that its new, dedicated high-volume testing immunoassay solution for the cobas 8000...


01 May, 2017, 08:30 ET One Month Until FDA's FSVP Deadline; Tools for Compliance by Registrar Corp

Many U.S. importers are required to comply with the U.S. Food and Drug Administration (FDA) Foreign Supplier Verification Program (FSVP) rule by...


28 Apr, 2017, 11:43 ET Novartis receives FDA approval for Rydapt® in newly diagnosed FLT3-mutated acute myeloid leukemia (AML) and three types of systemic mastocytosis (SM)

Novartis announced today the US Food and Drug Administration (FDA) has approved Rydapt® (midostaurin, formerly PKC412) for two indications. The...


28 Apr, 2017, 10:07 ET FDA approves new combination treatment for acute myeloid leukemia

The U.S. Food and Drug Administration today approved Rydapt (midostaurin) for the treatment of adult patients with newly diagnosed acute myeloid...


27 Apr, 2017, 18:58 ET Bayer Receives FDA Approval for Stivarga® (regorafenib) for the Second-Line Systemic Treatment of Liver Cancer

Bayer announced today that the U.S. Food and Drug Administration (FDA) approved Stivarga® (regorafenib) tablets for the second-line treatment of...


27 Apr, 2017, 15:31 ET At Vance Thompson Vision, New Dry Eye FDA Approval Leads Where No One Expected. Up Your Nose.

Allergan recently announced that it has received FDA approval for TrueTear™ Intranasal Tear Neurostimulator, the first and only FDA-cleared device...


27 Apr, 2017, 13:27 ET FDA approves first treatment for a form of Batten disease

The U.S. Food and Drug Administration today approved Brineura (cerliponase alfa) as a treatment for a specific form of Batten disease. Brineura is...


27 Apr, 2017, 13:11 ET FDA expands approved use of Stivarga to treat liver cancer

The U.S. Food and Drug Administration today expanded the approved use of Stivarga (regorafinib) to include treatment of patients with...


27 Apr, 2017, 12:35 ET Une entreprise canadienne obtient l'approbation de la FDA pour un nouveau produit d'alimentation animale visant à réduire les émissions mondiales de gaz à effet de serre

La Federal Drug Agency (FDA) des États-Unis accorde à l'entreprise Agrisoma Biosciences Inc., établie au Québec, l'autorisation réglementaire de...


27 Apr, 2017, 11:06 ET Novo Nordisk Receives FDA Approval of Saxenda® (liraglutide) injection 3 mg Label Update Including Long-Term Safety and Efficacy Data from 3-Year Trial

Novo Nordisk today announced that the US Food and Drug Administration (FDA) approved an updated product label for Saxenda® (liraglutide) injection...


26 Apr, 2017, 16:30 ET Mentor® Announces FDA Approval for MemoryGel® XTRA Silicone Gel-Filled Breast Implants

Mentor Worldwide LLC, a global leader in breast aesthetics, today announced that it has received approval from the U.S. Food & Drug...


26 Apr, 2017, 16:01 ET Impax Announces FDA Approval and Launch of a Generic Version of Vytorin® (Ezetimibe/Simvastatin Tablets)

Impax Laboratories, Inc. (NASDAQ: IPXL), a specialty pharmaceutical company, today announced it has received final U.S. Food and Drug...


26 Apr, 2017, 10:13 ET SOURCE-RAY INC. to Launch at UCAOA April 2017 Meeting

Source-Ray Inc., the largest American manufacturer of portable X-Ray systems announced today the FDA 510(k) approval for its new X-Ray unit - the...


26 Apr, 2017, 08:41 ET FDA Approves XATMEP™, the First and Only Ready-To-Use Methotrexate Oral Solution

Silvergate Pharmaceuticals, Inc. (www.silvergatepharma.com), leaders in the development and commercialization of innovative and safe medicines for...


26 Apr, 2017, 08:00 ET Inspirion Delivery Sciences Receives FDA Approval for RoxyBond™ (oxycodone hydrochloride) tablets CII, the First and Only Immediate Release Opioid Analgesic with Abuse-Deterrent Label Claims

Inspirion Delivery Sciences, LLC ("Inspirion") announced that the United States Food and Drug Administration (FDA) has approved RoxyBond™...


26 Apr, 2017, 07:30 ET Bausch + Lomb Receives 510(k) Clearance From FDA For Vitesse™, The First And Only Hypersonic, Open-Port Vitrectomy System

First Major Vitreous Removal Advancement in 40 Years to be Available Through the New Stellaris Elite™ Vision Enhancement System Valeant...


26 Apr, 2017, 01:00 ET Shire Granted EU Conditional Marketing Authorisation for Natpar[®▼] (Parathyroid Hormone) for the Treatment of Patients with Chronic Hypoparathyroidism

Shire plc (LSE: SHP, NASDAQ: SHPG) today announced that the European Commission (EC) has granted Conditional Marketing Authorisation for Natpar...


25 Apr, 2017, 11:58 ET La FDA actúa contra 14 empresas por vender tratamientos ilegales contra el cáncer

La Administración de Alimentos y Medicamentos de los Estados Unidos (FDA, por sus siglas en inglés) publicó el día de hoy las cartas de advertencia...