News FDA unveils framework for its expedited IND pilot The FDA has published the design of its expedited Investigational New Drug pilot, part of a plan to restore US competitiveness in clinical research.
R&D Understanding Operation Trialblazer, with Dr Harpreet Singh Dr Harpreet Singh, CMO at Precision for Medicine, brings both an insider and outsider perspective to discussing Operation TRIALBLAZER.
News Senate confirms Erica Schwartz as CDC Director CDC has a permanent director in place at last, after the Senate confirmed Erica Schwartz's nomination to what has become a politically charged role.
News HHS details plan to regain the US's edge in clinical trials The US launches a concerted effort to "restore American leadership in clinical trials" as it deals with the emergence of China as a global R&D hub.
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.
News Trump names Erica Schwartz to fill leadership void at CDC Former Deputy Surgeon General Erica Schwartz could end months at the CDC without Senate-confirmed leadership if she becomes Director.
News Lily gets FDA nod for SERD-CDK 4/6 combo in breast cancer Eli Lilly's imlunestrant (Inluriyo) for breast cancer has received a new FDA approval, in combination with CDK4/6 inhibitor abemaciclib (Verzenio).
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