News Industry alarm as FDA's CBER head Peter Marks resigns Industry organisations are alarmed by the resignation of senior FDA official Peter Marks, citing "misinformation and lies" by HHS Secretary Kennedy.
News Lilly to appeal after CHMP rejects Alzheimer's drug Kisunla The CHMP has advised against EU approval of Eli Lilly's Alzheimer's drug Kisunla, potentially handing an advantage to Eisai/Biogen's rival drug.
News Lilly adds Alzheimer's to its DTC platform LillyDirect Eli Lilly's DTC platform LillyDirect has been expanded to include in-person and telehealth services for people in the US living with Alzheimer's.
News Chiesi backs growth plans with a €430m new plant in Italy Fast-growing pharma group Chiesi has revealed plans to spend €430m on a new therapeutics manufacturing facility at its site in Milan.
News BIO rings alarm bells over Trump's pharma tariffs US tariffs on goods coming from Europe, China, and Canada could have a major impact on the biopharma industry and medicines access, says BIO.
News FDA clears first treatment for Prader-Willi syndrome Soleno Therapeutics' Vykat XR has become the first FDA-approved treatment for excessive eating in rare disorder Prader-Willi syndrome.
News AZ grabs FDA nod for Ultomiris in rare kidney disease IgAN AstraZeneca has staked a claim to the increasingly crowded IgAN market with an accelerated approval from the FDA for Ultomiris, its fifth indication.
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