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Scholar Rock plans to resubmit its BLA seeking approval of apitegromab, a first-in-class muscle-targeted therapy for spinal muscul...[ Price : $8.95]
CBER publishes a Standard Operating Policy and Procedure on IND administrative processing and review management procedures.[ Price : $8.95]
Strive Specialties, a compounding pharmacy, says in a suit filed in a Texas federal court that Eli Lilly and Novo Nordisk are viol...[ Price : $8.95]
FDA cites Biocon Biologics for a series of manufacturing and quality control deficiencies following an inspection of the companys ...[ Price : $8.95]
Reuters reports exclusively that FDA medical reviewers have slowed reviews on two drugs in the new Commissioners National Priority...[ Price : $8.95]
Jazz Pharmaceuticals sells its FDA Priority Review Voucher for $200 million to an undisclosed purchaser.[ Price : $8.95]
Charles River Laboratories names former FDA principal deputy commissioner Namandj N. Bumpus as senior vice president and chief sci...[ Price : $8.95]
FDA clears an iotaMotion 510(k) for an expanded pediatric indication for its iotaSOFT robotic-assisted cochlear implant insertion ...