Johnson & Johnson reports positive results from a late-stage clinical trial showing that its bispecific antibody therapy Tecvayli significantly improv...
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...
FDA clears a BD 510(k) for its EnCor EnCompass Breast Biopsy and Tissue Removal System, a new platform designed to allow clinicians to perform breast ...
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.
