FDA releases the form FDA-483 with eight observations from an inspection at Indias Shilpa Medicare drug manufacturing facility.
The ranking member of a House Select Committee on competition with China writes to three Chinese drug companies asking for detailed information on the...
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 ...
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...
