BridgeBio reports positive Phase 3 data for BBP-418 in limb-girdle muscular dystrophy patients as it plans an NDA filing in second quarter next year.
FDA releases a draft guidance outlining recommendations for medical device manufacturers on the type of Quality Management System information to inclu...
FDA posts a six-item Form FDA-483 after inspecting Hetero Labs Vishakapatnam, India, warehouse last month.
FDA approves an expanded indication for Mercks pulmonary arterial hypertension therapy Winrevair (sotatercept-csrk), clearing the drug to reduce the r...
FDA clears a YorLabs 510(k) for its new intracardiac imaging system that the company says could reshape workflows in catheterization labs.
Inhibrx Biosciences reports favorable data for treating chondrosarcoma with its antibody therapy ozekibart (INBRX-109).
FDA posts a two-item Form FDA-483 from an August inspection of Sumitomo Pharmas Suzuka, Japan, manufacturing facility.
An FDA payroll system error causes a paycheck delay for some FDA employees who are designated to continue working during the ongoing government shutdo...
