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 Dismay as Florida seeks to end vaccination protections Florida's plan to become the first US state to end all vaccine mandates, including children's pre-school shots, is labelled 'reckless'.
News Eisai moves swiftly to expand subcutaneous Leqembi label Before it has even launched, Eisai has filed to widen subcutaneous Leqembi's label to include starting as well as maintenance dosing in Alzheimer's.
News A vaccine adcomm expert criticised RFK Jr – now he's out A prominent critic of RFK Jr's approach to vaccination regulation, Dr Paul Offit, has been removed from an influential FDA advisory committee.
News Ex-CDC chiefs sound alarm bells over HHS under Kennedy No fewer than nine former directors of the CDC have said every American should be alarmed at what is happening on HHS Secretary Kennedy's watch.
News Outlook blindsided as FDA blocks wet AMD drug once again Shares in Outlook Therapeutics lost more than half their value after the FDA turned down the company's marketing application for its wet AMD therapy.
News Repligen builds in cell therapy with $1.5bn BioLife takeover Repligen has reached a deal to buy cell therapy specialist BioLife Solutions for $1.5bn, tapping into a market growing at breakneck speed.
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