Capricor Therapeutics recently presented data from its Phase 3 HOPE-3 trial of Deramiocel for Duchenne muscular dystrophy at the 2026 American Academy of Neurology meeting, highlighting statistically ...
The FDA has assigned mRNA-1010 a PDUFA target date of 5 August 2026. If approved, mRNA-1010 will be the first seasonal ...
The FDA has accepted the NDA for ulixacaltamide HCl, a selective T-type calcium channel inhibitor for essential tremor, following positive phase 3 Essential3 trial results.
FDA recently released two draft guidance documents for industry related to cell and gene therapy (CGT) products as the agency seeks to advance the efficient development and review of safe and ...
FDA assigned PDUFA target action date of January 29, 2027No advisory committee meeting expectedBOSTON, April 14, 2026 (GLOBE NEWSWIRE) -- ...
Prescription Drug User Fee Act (PDUFA) target date of October 2026 ---- Submission supported by CESSA Phase 3 trial results demonstrating ...
LEXINGTON, Mass.--(BUSINESS WIRE)-- Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat ...
A new report from Booz Allen Hamilton commissioned by the US Food and Drug Administration (FDA) recommends refinements to the agency’s workload capacity planning adjustment methodology for its ...
The pharmaceutical and biopharmaceutical industries have long been supportive of the user fee schemes used to fund the US Food and Drug Administration (FDA). Originally passed under the Prescription ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results