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 FDA unveils swift route to market for personalised drugs FDA reveals a regulatory pathway for personalised therapies based on 'plausible mechanism', drawing on the bespoke gene-editing treatment of Baby KJ.
News FDA releases previously unseen CRLs in transparency push The FDA's earlier decision to publish complete response letters was largely a repackaging of existing information, but now it has gone much further.
News Just how radical is the FDA's complete response letter move? The FDA says publishing complete response letters for medicines is an act of "radical transparency," but it is not as revolutionary as it seems.
News Makary, Prasad set out their vision for the FDA Top FDA officials have spelled out their strategic priorities in the coming years, including the use of AI to "increase efficiency."
News CDC stops backing COVID jabs for pregnant women, children In a new sign of downgraded support for COVID-19 shots by the US administration, the CDC has stopped backing vaccines for pregnant women and children.
News EMA advisors say CSL's Tavneos should be pulled from sale Pressure is building on Amgen to withdraw rare disease therapy Tavneos, after the CHMP recommended its marketing authorisation by revoked in the EU.
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