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

Dec 10, 2018, 21:00 ET Astellas Launches XOSPATA® (gilteritinib) in the U.S. for the Treatment of Adult Patients with Relapsed/Refractory Acute Myeloid Leukemia (AML) with a FLT3 Mutation

Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D. "Astellas") today announced that XOSPATA® (generic name: gilteritinib) is...


Dec 10, 2018, 15:46 ET FDA clears mobile medical app to help those with opioid use disorder stay in recovery programs

Today, the U.S. Food and Drug Administration cleared a mobile medical application (app) to help increase retention (the amount of time a patient...


Dec 10, 2018, 10:00 ET Merck KGaA, Darmstadt, Germany Announces FDA Orphan Drug Designation for Bifunctional Immunotherapy M7824 in Biliary Tract Cancer

The information contained is not intended for distribution in the UK FDA grants M7824, an investigational bifunctional immunotherapy, orphan drug...


Dec 10, 2018, 09:00 ET Stealth BioTherapeutics Granted Fast Track Designation for Elamipretide for the Treatment of Dry Age-Related Macular Degeneration with Geographic Atrophy

Stealth BioTherapeutics (Stealth), a clinical-stage biopharmaceutical company developing therapeutics to treat mitochondrial dysfunction, today...


Dec 07, 2018, 07:45 ET Contego Medical Receives 510(k) Clearance for the Vanguard IEP Peripheral Angioplasty System with Integrated Embolic Protection

Contego Medical announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its Vanguard IEP® Peripheral...


Dec 06, 2018, 13:18 ET Produto de alta tecnologia para medir a glicemia já é realidade para os pacientes do SUS

No último dia 16 de novembro de 2018, conforme a resolução de número 3.161 publicada no Diário Oficial da União, a Agência Nacional de Vigilância...


Dec 05, 2018, 09:34 ET Prometic to Initiate PBI-4050 Pivotal Phase 3 Clinical Trial in Alström Syndrome

Clinical-regulatory pathway defined following recent meetings with regulatory authorities Pivotal Phase 3 clinical trial design finalized to support...


Dec 05, 2018, 09:31 ET Olympus Spiration® Valve System Is FDA Approved for the Endobronchial Treatment of Emphysema

Olympus, a global technology leader in designing and delivering innovative solutions for medical and surgical procedures, among other core...


Dec 05, 2018, 08:00 ET Bausch + Lomb Receives 510(K) Clearance From FDA For Bausch + Lomb Ultra® Multifocal For Astigmatism Contact Lenses

Bausch + Lomb, a leading global eye health company and wholly owned subsidiary of Bausch Health Companies Inc. (NYSE/TSX: BHC), today announced that...


Dec 05, 2018, 07:00 ET Subtle Medical Receives FDA 510(k) Clearance and CE Mark Approval for SubtlePET™

Subtle Medical, a privately-held medical device company focused on improving medical imaging efficiency and patient experience with innovative deep...


Dec 04, 2018, 19:00 ET Innovent Receives an Approval from the US FDA to Initiate Clinical Trials for its Anti-OX40 Monoclonal Antibody IBI101

Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class China-based biopharmaceutical company that develops and commercializes high quality...


Dec 03, 2018, 09:49 ET Notal Vision Announces FDA Grants Breakthrough Device Designation for Pioneering Patient-Operated Home Optical Coherence Tomography (OCT) System

Notal Vision, Ltd., ("Notal") a privately-held ophthalmic diagnostic services company, focused on advancing eye care by extending ophthalmic disease...


Dec 03, 2018, 09:00 ET Alma, a Sisram Medical Company, Receives Notice of Completion of Inquiry from FDA for FemiLift[TM] Pixel CO2 System

Alma Lasers, LTD, a global developer of innovative energy-based solutions for the aesthetic and surgical markets, announced today that it received a...


Dec 03, 2018, 08:30 ET Edwards Receives Clearance For HemoSphere Platform With Intelligent Decision-Support Tools

Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care...


Dec 03, 2018, 08:12 ET CASI Pharmaceuticals Announces China Market Approval Of Melphalan Hydrochloride For Injection (Trademark: EVOMELA®)

CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company dedicated to the development and delivery of high quality, cost-effective...


Dec 03, 2018, 08:00 ET FDA Grants Breakthrough Device Designation for CTEPH Pattern Recognition Artificial Intelligence Software from Bayer and Merck

Bayer announced today that the U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation to the Chronic Thromboembolic...


Dec 03, 2018, 08:00 ET Eiger BioPharmaceuticals Announces FDA Acceptance of IND Application for Lonafarnib for the Treatment of Progeria and Progeroid Laminopathies

Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR), focused on the development and commercialization of targeted therapies for rare and ultra-rare...


Nov 29, 2018, 10:18 ET FDA Accepts Filing of New Estrogen-free Oral Contraceptive Developed by Exeltis

This new method of contraception could offer an improved bleeding profile and greater flexibility for female population Slinda® has demonstrated that ...


Nov 28, 2018, 19:25 ET XOSPATA® (gilteritinib) Approved by U.S. FDA for Adult Patients with Relapsed/Refractory Acute Myeloid Leukemia (AML) with a FLT3 Mutation

Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D. "Astellas") today announced that the U.S. Food and Drug Administration...


Nov 28, 2018, 18:20 ET FDA approves first treatment for Lambert-Eaton myasthenic syndrome, a rare autoimmune disorder

The U.S. Food and Drug Administration today approved Firdapse (amifampridine) tablets for the treatment of Lambert-Eaton myasthenic syndrome (LEMS)...


Nov 28, 2018, 14:46 ET FDA approves treatment for adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a certain genetic mutation

The U.S. Food and Drug Administration today approved Xospata (gilteritinib) tablets for the treatment of adult patients who have relapsed or...


Nov 28, 2018, 13:47 ET FDA approves first biosimilar for treatment of adult patients with non-Hodgkin's lymphoma

The U.S. Food and Drug Administration today approved Truxima (rituximab-abbs) as the first biosimilar to Rituxan (rituximab) for the treatment of...


Nov 28, 2018, 08:00 ET FDA Approves Expanded Use for Ortho Clinical Diagnostics VITROS® HIV Combo Test

Ortho Clinical Diagnostics, a global leader of in vitro diagnostics, announced that its VITROS® Immunodiagnostic Products HIV Combo Reagent Pack and...


Nov 27, 2018, 10:00 ET HighTide Therapeutics Receives Fast Track Designation from the U.S. FDA for HTD1801 Treating Nonalcoholic Steatohepatitis (NASH)

HighTide Therapeutics Inc., a clinical-stage biopharmaceutical company, announced that the U.S. FDA has granted Fast Track Designation to its...


Nov 27, 2018, 08:00 ET United Orthopedic Corporation Announces FDA Clearance for Vitamin E Highly Cross-Linked Polyethylene Hip Liner

United Orthopedic Corporation, a leading international designer, manufacturer, and distributor of innovative orthopedic implants and instruments,...