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 Recordati gets €10.9bn takeover bid from private equity firm Recordati has received a takeover offer from private equity group CVC that, if completed, would delist it from the Italian stock exchange.
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 FDA issues warning letters to five unapproved GLP-1 websites In a handful of strongly-worded warning letters, the FDA is cracking down on sales of unapproved peptides - even if they're labelled for research.
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