News UCB brings first therapy for rare disease TK2d to EU The EU has approved UCB's Kygevvi for rare disease TK2d, and Sanofi's acute GvHD therapy Rezurock, in a pair of decisions announced this morning.
News Amgen's BiTE for lung cancer backed for EU approval Amgen's fast-growing bispecific T-cell engager Imdylltra should be cleared as a second-line therapy for small cell lung cancer, said the CHMP.
News Touchdown for Rocket as its first gene therapy gets US okay Rocket Pharma has won FDA approval for the first gene therapy for LAD-I, a devastating genetic disorder causing severe vulnerability to infections.
News Corcept gets FDA OK for first-in-class ovarian cancer drug Corcept shares surge on FDA approval of Lifyorli, a first-in-class selective glucocorticoid receptor antagonist for ovarian cancer.
News FDA clears Denali's 'game-changer' Hunter syndrome drug Denali's Avlayah is the first drug for neurological complications associated Hunter syndrome to be approved in the US.
News Anavex sinks after pulling Alzheimer's filing in EU Shares in Anavex Life Sciences lost more than a third of their value today after the company abandoned an EU filing for its Alzheimer's therapy.
News Regenxbio's Duchenne gene therapy clears phase 3 hurdle Regenxbio is pitching at FDA approval in 2027 for its Duchenne muscular dystrophy gene therapy RGX-202, a potential rival to Sarepta/Roche's Elevidys.
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