News After refusing to resign, CDER head Høeg is fired The turmoil at the FDA continues with the news that Tracy Beth Høeg has been fired as acting head of CDER, to be replaced by Michael Davis.
News Reports: Makary out, Diamantas in as FDA commissioner According to multiple press reports citing anonymous insider sources, Dr Marty Makary has resigned after a year at the head of the FDA.
News Is Makary on the way out, and who might replace him? Marty Makary's position as FDA Commissioner is said to be in jeopardy, raising the threat of further chaos at the agency if he is ousted.
Oncology Dose optimisation in oncology: Insights from AACR 2026 and i... Five years after its launch, the FDA’s Project Optimus remained a key theme in discussions at AACR 2026.
News Amgen, AZ will pilot FDA's real-time clinical trial plan The FDA has published a plan to allow data from clinical trials to be reported to the agency as they occur in real time.
News FDA grants three priority vouchers to psychedelics The FDA dropped a surprise Friday announcement that three more National Priority Vouchers would be given to a trio of psychedelics companies.
News Bayer gets swift review for Kerendia in type 1 diabetes FDA starts a priority review of Bayer's Kerendia for chronic kidney disease in type 1 diabetes, which could end a 30-year drought in new therapies.
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