Former FDA commissioner Robert Califf accepts split positions as vice chancellor for health data science for Duke Health and senior manager at Verily ...
AstraZeneca petitions FDA to require certain conditions for a Teva 505(b)(2) application referencing Faslodex IM injection as the listed drug.
FDA clears an Exactech 510(k) to market the ExactechGPS Shoulder Application that combines preoperative planning with computer-assisted shoulder arthr...
Former FDA deputy commissioner William Schultz makes the case for not relaxing the agencys efficacy standard to allow drug companies to provide truthf...
FDA approves a Vertex Pharmaceuticals expanded use of Kalydeco (ivacaftor) for treating cystic fibrosis.
Former FDA commissioner Robert Califf accepts split positions as vice chancellor for health data science for Duke Health and senior manager at Verily ...
FDA places a Concert Pharmaceuticals study of its hair loss therapy, CTP-543, on clinical hold to allow the agency to review requested data.
FDA grants Bayer a priority review on its NDA for copanlisib for treating relapsed or refractory follicular lymphoma patients who have received at lea...