News J&J gets EU approval for Imaavy in gMG J&J's Imaavy has become the first FcRn blocker to be approved in the EU for both adolescent and adult patients with generalised myasthenia gravis.
News FDA doubles down on its push into AI The FDA has revealed the latest element in its adoption of AI, an agentic AI platform that agency staffers can use to streamline complex tasks.
News UK and US agree zero tariffs on pharma – with price rises A deal between the UK and the US will maintain tariffs on imports into the US at 0%, but prices of medicines used by the NHS will go up.
News EMA starts review of 'transformative' bladder cancer therapy The EMA has started a review of a regimen based on Pfizer/Astellas' Padcev and MSD's Keytruda that is described as a game-changer for bladder cancer.
News Is FDA about to restrict vaccination even further? Vinay Prasad, head of CBER, is reported to be planning to tighten regulations on vaccines after concluding that COVID-19 shots caused 10 child deaths.
News Innovent gets OK for China's first home-grown IL-23p19 drug Innovent has picked up approval in China for Pecondle, its anti-IL-23p19 antibody, as a treatment for moderate-to-severe plaque psoriasis.
News Trial miss doesn't dent Biogen's faith in Alzheimer's drug Biogen will advance its tau-targeting Alzheimer's disease drug diranersen into phase 3, even though it missed the main endpoint in a midstage trial.
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