News Santhera shores up funding ahead of vamorolone verdict The FDA is due to deliver a verdict on vamorolone in Duchenne muscular dystrophy in October.
News Northern Ireland Brexit deal restores MHRA jurisdiction Regulator regains the power to approve medicines in Northern Ireland under Windsor Framework.
News US states sue FDA over access to abortion pills The complaint is asking the FDA to relax "onerous" REMS restrictions on mifepristone.
News J&J gets restricted label for PARP drug Akeega in EU Drug is backed for BRCA+ prostate cancer patients only, a narrower group than rival Lynparza.
News Merck will appeal EU rejection of COVID drug Lagevrio CHMP says evidence for the drug is “not adequate” to show efficacy over standard care.
News Sanofi gets FDA nod for long-acting haemophilia A drug Once-weekly Altuviiio could be potential $2 billion-plus blockbuster, according to analysts.
News FDA relents and will review Moderna's flu shot The FDA will start a review of Moderna's flu jab mRNA-1010, after refusing to accept the filing last week, with a new "regulatory approach."
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