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 Medicare obesity drug pilot extended after insurer pushback Medicare will cover the cost of a pilot of weight-loss drug coverage, after health insurers refuse to take part.
News Trump signs order to hasten psychedelic medicine access Donald Trump has signed an executive order directing the FDA to reduce regulatory hurdles that stand in the way of bringing psychedelics to patients.
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 FDA accelerated approval path needs improvement, says ICER The FDA's accelerated approval route has delivered important new drugs to patients quicker, but is opaque and plagued by inconsistencies, says ICER.
News Chiesi signs $1.9bn deal to buy KalVista and its HAE drug Chiesi has boosted its rare disease business with an agreement to buy KalVista and Ekterly, its oral drug for treating attacks in rare disease HAE.
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