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Two drug companies comment on an FDA draft guidance on developing drugs and biologics for adjuvant treatment of bladder cancer.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...
Federal Register notice: FDA renews its Pharmacy Compounding Advisory Committee for an additional two years.
Some 76 healthcare organizations call on congressional leaders to approve increased funding for FDA and other key health agencies in the FY 21 budget ...