FDA PDUFA Date

U.S. FDA Accepts Acadia's Filing For Rett Syndrome Candidate Under Priority Review
FDA Accepts Menarini Group and Radius Health's Filing Under Priority Review For Breast Cancer Candidate
FDA Accepts MediWound's Refiling For Severe Thermal Burns Therapy For Review
FDA Accepts Menarini Group and Radius Health's Filing Under Priority Review For Breast Cancer Candidate
FDA Accepts MediWound's Refiling For Severe Thermal Burns Therapy For Review
SCYNEXIS Shares Climb As FDA Accepts Filing For Vaginal Yeast Infection Candidate Under Priority Review
FDA Accepts Gamida's Filing For Stem Cell Transplant Candidate Under Priority Review

FDA PDUFA Date Recent News

FDA Accepts AstraZeneca's Submission For Low Breast Cancer Candidate Under Priority Review
The United States Food and Drug Administration (FDA) has accepted to review the supplemental Biologics License Application (sBLA) of AstraZeneca (NASDAQ: AZN) and Daiichi Sankyo’s lead asset ENHERTU (fam-trastuzumab deruxtecan-nxki) for the treatment of adult patients with unresectable
Apellis Shares Climb As FDA Accepts Geographic Atrophy Candidate Submission Under Priority Review
The U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review designation for Apellis Pharmaceuticals’ (NASDAQ: APLS) New Drug Application (NDA) for the intravitreal pegcetacoplan. The regulatory agency has assigned target action date of November 26, 2022.
U.S. FDA Accepts Regeneron's Diabetic Retinopathy Candidate Submission For Review
The U.S. Food and Drug Administration (FDA) has accepted Regeneron Pharmaceuticals’ (NASDAQ: REGN) supplemental Biologics License Application (sBLA) of EYLEA (aflibercept) Injection for review in patients with diabetic retinopathy (DR).