News Mesoblast finally pushes GvHD cell therapy over finish line At its third attempt, Mesoblast has secured FDA approval for the first-ever mesenchymal stem cell (MSC) therapy, Ryoncil for acute GvHD in children.
News FDA clears Neurocrine drug for rare adrenal disorder Neurocrine Bioscience's Crenessity is the first new option for classic congenital adrenal hyperplasia (CAH) in more than 70 years.
News Galderma adds new indication for blockbuster hope Nemluvio Galderma has claimed a second FDA approval for IL-31 inhibitor Nemluvio, adding atopic dermatitis to its label.
News Makary confirmed as Trump's FDA pick, with Weldon for CDC Martin Makary has been confirmed as Donald Trump's pick for FDA Commissioner, while Dave Weldon has been selected as his pick for CDC Director
News Is Martin Makary Trump's pick for FDA Commissioner? US President-elect Donald Trump is reported to be considering the nomination of Johns Hopkins surgeon and writer Martin Makary to lead the FDA
News FDA experts lukewarm on AZ's anticoagulant antidote Andexxa AstraZeneca is facing some pushback as it tries to upgrade anticoagulant antidote drug Andexxa to full approval in the US
Oncology Getting predictive technologies to patients, with Concr Dr Irina Babina, CEO of oncology R&D platform Concr, discusses how current regulatory frameworks were built for static diagnostics.
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