regulatory approval

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BMS beats MSD to the US subcutaneous PD-1 inhibitor market after Opdivo Qvantiq is cleared across nearly all the indications of the IV form.

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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.

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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.

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Ionis Pharma's Tryngolza (olezarsen) has become the first FDA-approved drug therapy for adults with rare disease familial chylomicronaemia syndrome.

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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.

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At its third attempt, Mesoblast has secured FDA approval for the first-ever mesenchymal stem cell (MSC) therapy, Ryoncil for acute GvHD in children.