Scholar Rock plans to resubmit its BLA seeking approval of apitegromab, a first-in-class muscle-targeted therapy for spinal muscular atrophy.
CBER publishes a Standard Operating Policy and Procedure on IND administrative processing and review management procedures.
Strive Specialties, a compounding pharmacy, says in a suit filed in a Texas federal court that Eli Lilly and Novo Nordisk are violating antitrust laws...
FDA cites Biocon Biologics for a series of manufacturing and quality control deficiencies following an inspection of the companys drug substance manuf...
Reuters reports exclusively that FDA medical reviewers have slowed reviews on two drugs in the new Commissioners National Priority Voucher Program due...
Jazz Pharmaceuticals sells its FDA Priority Review Voucher for $200 million to an undisclosed purchaser.
Charles River Laboratories names former FDA principal deputy commissioner Namandj N. Bumpus as senior vice president and chief scientific and innovati...
FDA sends an untitled letter to Altor BioScience, alleging that promotional Web pages for bladder cancer drug Anktiva are false or misleading and viol...
