News FDA advisors will look at full Leqembi approval in June The FDA has convened a meeting of an advisory committee in June to consider the bid by Eisai and Biogen to convert their accelerated approval of Alzheimer’s disease therap
News FDA advisors split on Biogen’s ALS therapy But unanimous vote on biomarker validity could support accelerated approval of tofersen.
News Double blow for Sangamo as Novartis, Biogen exit deals The two deals for gene-modifying candidates were worth up to $3.1 billion including milestones.
News First major insurer covers Eisai’s Alzheimer’s drug Leqembi Department of Veterans Affairs will cover the drug for veterans with early-stage Alzheimer's.
News FDA sets July verdict date for Leqembi, after adcomm meeting After priority review, regulator will consider upgrading the drug's status to full approval.
News CMS accused of discrimination over Alzheimer’s drug verdict Decision not to revisit coverage decision for amyloid drugs is slammed by patient groups.
News Infex chases after Insmed with bronchiectasis trial win UK biotech Infex is in hot pursuit of Insmed's Brinsupri, the only approved therapy for non-CF bronchiectasis, with its quarterly-dosed antibody.
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