News GSK bags breakthrough status for bone cancer drug GSK has claimed its second breakthrough designation from the FDA for B7-H3-targeted ADC, this time in osteosarcoma.
News FDA issues first guidance on AI in medicine development The FDA has placed the credibility of AI's 'context of use' in pharma development at the heart of its first guidance in this area.
News Capricor files cell therapy for DMD cardiomyopathy with FDA Capricor completes its US filing for deramiocel, vying to become the first FDA-approved therapy for cardiomyopathy in Duchenne muscular dystrophy.
News Daiichi and AZ pull Dato-DXd filing in Europe too AstraZeneca and Daiichi Sankyo have decided to voluntarily withdraw their EU marketing application for Dato-DXd in lung cancer.
News MSD eyes June verdict for paediatric RSV antibody The FDA has started a review of MSD's RSV antibody clesrovimab, a potential rival to Beyfortus, with a verdict due in the middle of next year.
News FDA dents J&J's blockbuster hopes for Rybrevant FDA has sent a complete response letter to J&J, denying approval of its subcutaneous version of lung cancer therapy Rybrevant.
News GBL joins CVC in €10.7bn takeover bid for Recordati A consortium of investors has made a €10.7bn offer to take Italian pharma Recordati private, but some analysts are sceptical the deal will go through.
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