FDA updates its 2019 safety communication on Endologixs AFX endovascular graft systems used in treating abdominal aortic aneurysms and the risks assoc...
Federal Register notice: FDA makes available a final guidance entitled Requesting FDA Feedback on Combination Products.
FDA clears an Ensemble Orthopedics 510(k) for its Ensemble CMC Implant for treating patients with early-stage osteoarthritis of the carpometacarpal jo...
FDA approves labeling changes on Mercks Januvia (sitagliptin), Janumet (sitagliptin and metformin hydrochloride), and Janumet XR (sitagliptin and metf...
Federal Register notice: FDA corrects an 11/25 notice on a guidance entitled Formal Meetings Between the Food and Drug Administration and Abbreviated ...
Two drug companies comment on an FDA draft guidance on developing drugs and biologics for adjuvant treatment of bladder cancer.
Genus asks a Maryland federal court to require FDA to withdraw its approval of Lannett Numbrino because Lannett made materially untrue statements in i...
FDA watchers speculate that former commissioner David Kessler and former principal deputy commissioner Joshua Sharfstein are top contenders for the ag...