Just-appointed FDA chief counsel Hilary Perkins abruptly resigns her post after two days on the job.
Federal Register notice: FDA issues a priority review voucher was issued to SpringWorks Therapeutics for achieving a 2/11 NDA approval for Gomekli (mi...
FDA warns Fremont, CA-based QApel Medical about illegally marketing an aspiration system with Quality System Regulation violations.
Researchers say that nearly one-third of adverse event reports submitted to the FDA MAUDE medical device database came in later than allowed by regula...
The Senate Health Education Labor and Pensions Committee votes to advance the nomination of Marty Makary as FDA commissioner.
FDA warns staff returning to offices on 3/17 that they can face parking and workspace issues, Reuters reports.
FDA clears a Canon Medical 510(k) for artificial intelligence enhancements for the Aquilion One/Insight Edition CT scanner.
Amgen says it will file a BLA supplement by 6/30 for Uplizna (inebilizumab-cdon) to expand its use to treat adults living with generalized myasthenia ...
