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 SCOTUS retains telemedicine access to abortion pill The Supreme Court of the US has ruled that abortion pill mifepristone can continue to be prescribed remotely and delivered by mail-order – for now.
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 Danco fights back after US court curbs abortion pill access In another setback for abortion care in the US, an appeals court has issued an order restricting the distribution of mifepristone through the mail.
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 clears first genetic hearing loss gene therapy Regeneron's Otarmeni is the first gene therapy for congenital hearing loss to be cleared by the FDA, and will be made available for free in the US.
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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