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 FDA approves flurry of drugs ahead of holiday season The FDA has wrapped up a series of new approvals as 2024 draws to a close, with Novo Nordisk, Pfizer, Vertex, and Hikma among the beneficiaries.
News AZ gets EU okay for Tagrisso in early-stage lung cancer AstraZeneca's EGFR inhibitor Tagrisso has become the first drug in the class to be approved in the EU for a form of early-stage lung cancer.
News FDA clears Ionis drug as first therapy for rare disease FCS Ionis Pharma's Tryngolza (olezarsen) has become the first FDA-approved drug therapy for adults with rare disease familial chylomicronaemia syndrome.
News Lilly grabs first-ever FDA nod for a sleep apnoea drug Lilly's Zepbound has become the first drug approved by the FDA for obese patients with obstructive sleep apnoea, which affects millions in the US.
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 Dexcom is first to join FDA/CMS health tech pilot The FDA has named Dexcom as the first company to take part in its TEMPO pilot, which aims to bring digital health tech to patients more quickly.
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