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
17:25 ET Novartis CAR-T cell therapy CTL019 unanimously (10-0) recommended for approval by FDA advisory committee to treat pediatric, young adult r/r B-cell ALL
Novartis announced today that the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) unanimously (10-0) recommended...
16:27 ET AMCP-Supported Bill to Create Safe Harbor for Pre-FDA-Approval Product Communications is Examined in House Subcommittee on Health Hearing
The U.S. House Energy and Commerce Committee's Subcommittee on Health held a hearing today on the "Pharmaceutical Information Exchange (PIE) Act of...
08:11 ET Saebo Announces FDA Clearance of SaeboVR - World's First Virtual ADL Rehabilitation System
Saebo, Inc. announced on Wednesday that the U.S. Food and Drug Administration (FDA) has cleared SaeboVR, a virtual ADL (activities of daily living)...
07:30 ET
Oxitec's Friendly™ Aedes Mosquito Receives Positive Evaluation for European Standard in relation to Human Health and the Environment
The National Institute of Public Health and the Environment (RIVM) in the Netherlands today published its "Technical evaluation of a potential...
07:30 ET
El mosquito Aedes Amigable™ de Oxitec recibe una evaluación positiva para el Estándar Europeo relacionado con la Salud Humana y el Medio Ambiente
El Instituto Nacional de Salud Pública y Medio Ambiente (RIVM) de los Países Bajos ha publicado hoy su «Evaluación técnica de una liberación...
Jul 11, 2017, 19:22 ET FDA Grants Full Approval for BLINCYTO® (blinatumomab) to Treat Relapsed or Refractory B-cell Precursor Acute Lymphoblastic Leukemia in Adults and Children
Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application...
Jul 11, 2017, 14:07 ET Dornier MedTech Launches the DORNIER DELTA® III - Most Advanced Kidney Stone Treatment Lithotripter
Dornier MedTech® America, a global medical device company and the pioneer of Extracorporeal Shock Wave Lithotripsy (ESWL®), has received FDA...
Jul 11, 2017, 09:00 ET Stryker's MultiGen® 2 Radiofrequency Generator Receives FDA 510(k) Clearance
Stryker announced today that it has received FDA 510(k) clearance for its MultiGen 2 RF Generator. This product provides physicians with the...
Jul 11, 2017, 07:07 ET FDA Clears Pesticide-Free Resultz® Lice & Egg Elimination Kit
Piedmont Pharmaceuticals announces it has received clearance from the U.S. Food and Drug Administration for its patented, pesticide-free RESULTZ®...
Jul 07, 2017, 15:57 ET The U.S. Food & Drug Administration Approves Endari™ (L-glutamine oral powder), the First and Only Treatment for Sickle Cell Disease in Pediatric Patients and First in Nearly 20 Years for Adults
Emmaus Life Sciences Inc. announced today that the U.S. Food and Drug Administration (FDA) approved Endari™ (L-glutamine oral powder) to reduce the...
Jul 07, 2017, 11:40 ET FDA approves new treatment for sickle cell disease
The U.S. Food and Drug Administration today approved Endari (L-glutamine oral powder) for patients age five years and older with sickle cell...
Jul 06, 2017, 18:07 ET BMS' Orencia Plunges into the Fray of Battle for Alternative MOA for Psoriatic Arthritis with Recent FDA Approval.... Can it Find a Unique Space to Play?
BMS' Orencia, already indicated for Rheumatoid Arthritis, gained FDA approval for use in patients with Psoriatic Arthritis (PsA). In RealTime...
Jul 05, 2017, 17:02 ET Impax Announces FDA Approval and Launch of Additional Strengths of Generic Focalin XR® (Dexmethylphenidate Hydrochloride) Extended-Release Capsules CII
Impax Laboratories, Inc. (NASDAQ: IPXL), a specialty pharmaceutical company, today announced it has received final U.S. Food and Drug...
Jul 05, 2017, 14:37 ET Breckenridge Announces Final Approval for Omeprazole Delayed-Release Capsules
Breckenridge Pharmaceutical, Inc. announced today it has received U.S. Food and Drug Administration final approval of its abbreviated new drug...
Jul 05, 2017, 09:00 ET Edwards' INSPIRIS RESILIA Valve Receives FDA Approval
Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical...
Jul 03, 2017, 13:34 ET FDA clears expanded use of cooling cap to reduce hair loss during chemotherapy
Today, the U.S. Food and Drug Administration cleared the expanded use of a cooling cap, DigniCap Cooling System, to reduce hair loss (alopecia)...
Jun 30, 2017, 08:00 ET Debiopharm International SA et Arbor Pharmaceuticals, LLC annoncent avoir reçu l'autorisation de mise sur le marché (AMM) de la part de la FDA américaine pour Triptodur™, une formulation à base de Triptoréline administrée tous les 6 mois, pour le traitement de la puberté précoce centrale (PPC)
Il a été démontré que Triptodur (triptoréline), suspension injectable à libération prolongée, pouvait enrayer ou inverser les signes cliniques de...
Jun 30, 2017, 08:00 ET Arbor Pharmaceuticals, LLC and Debiopharm International SA Announce U.S. FDA Approval for Triptodur™, Triptorelin 6-month Formulation, in the Treatment of Central Precocious Puberty (CPP)
Arbor Pharmaceuticals, LLC, a U.S.-based specialty pharmaceutical company, and Debiopharm International SA, part of Debiopharm Group™, a...
Jun 29, 2017, 17:30 ET FDA Approves Vectibix® (Panitumumab) For Use In Wild-Type RAS Metastatic Colorectal Cancer
Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application...
Jun 29, 2017, 13:03 ET AMPHORA® (L-lactic Acid, citric acid, and potassium bitartrate) Receives "Qualified Infectious Disease Product" (QIDP) Designation from the FDA
Evofem Biosciences, a biotechnology company focused on the development and commercialization of women's health products, today announced...
Jun 29, 2017, 12:22 ET Sorrento Therapeutics Announced FDA Authorization of IND to Commence Clinical Trial of RTX in Intractable Cancer Pain
Sorrento Therapeutics, Inc. (NASDAQ: SRNE, "Sorrento"), announced today that the U.S. Food and Drug Administration (FDA) has authorized the...
Jun 29, 2017, 10:31 ET FDA unveils plan to eliminate orphan designation backlog
Today, the U.S. Food and Drug Administration unveiled a strategic plan to eliminate the agency's existing orphan designation request backlog and...
Jun 29, 2017, 03:44 ET Norgine anuncia la aceptación de la FDA para la solicitud de aprobación de PLENVU® (NER1006)
La fecha de lanzamiento se establece para el primer trimestre de 2018 Norgine B.V. ha anunciado hoy que ha recibido la aceptación de la...
Jun 28, 2017, 18:45 ET Norgine erklärt FDA-Annahme des Zulassungsantrags für PLENVU® (NER1006)
Erstes Quartal 2018 als Einführungsdatum anvisiert Wie Norgine B.V. heute bekanntgab, hat es die Annahme des NDA-Antrags (New Drug Application,...
Jun 28, 2017, 18:36 ET Norgine annonce l’acceptation du dossier déposé auprès de la FDA pour PLENVU® (NER1006)
Date de lancement fixée au premier trimestre 2018 Norgine B.V. a annoncé aujourd'hui qu'il a reçu l'acceptation de l'Agence américaine des...
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Jul 07, 2017, 15:57 ET The U.S. Food & Drug Administration Approves Endari™ (L-glutamine oral powder), the First and Only Treatment for Sickle Cell Disease in Pediatric Patients and First in Nearly 20 Years for Adults
Jul 11, 2017, 19:22 ET FDA Grants Full Approval for BLINCYTO® (blinatumomab) to Treat Relapsed or Refractory B-cell Precursor Acute Lymphoblastic Leukemia in Adults and Children
Jul 11, 2017, 09:00 ET Stryker's MultiGen® 2 Radiofrequency Generator Receives FDA 510(k) Clearance
Jun 22, 2017, 17:02 ET FDA Approves First Companion Diagnostic Test to Simultaneously Screen for Multiple Non-Small Cell Lung Cancer Therapies
Jun 22, 2017, 17:02 ET FDA Approves First Companion Diagnostic Test to Simultaneously Screen for Multiple Non-Small Cell Lung Cancer Therapies
