FDA posts a seven-item Form FDA-483 after inspecting Dr. Reddys Mirfield, West Yorkshire, UK, active pharmaceutical ingredient manufacturing facility ...
Intellia Therapeutics pauses two Phase 3 trials of nex-z, a CRISPR-based therapy for transthyretin amyloidosis with cardiomyopathy and polyneuropathy,...
A Senate Committee demands answers from HHS on what they describe as serious national security and public health risks tied to Americas dependence on ...
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FDA releases a draft guidance outlining recommendations for medical device manufacturers on the type of Quality Management System information to inclu...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.
