News PepGen slumps as FDA places hold on lead drug Shares in PepGen fell sharply after the FDA placed a partial clinical hold on its lead drug for rare neuromuscular disease DM1.
News FDA ramps up its pushback against compounded GLP-1s In a move that will please Novo Nordisk and Eli Lilly, the FDA sent warnings to 30 telehealth firms, accusing them of illegally marketing GLP-1 drugs.
News New FDA knockback hits uniQure and Huntington patients hard uniQure looks like it may have to run another trial of its Huntington's disease gene therapy AMT-130, delaying the highly anticipated programme.
News US lawmakers take FDA to task over rare diseases record Lawmakers and patient advocates in the US are concerned that the FDA's regulation of rare disease therapies has been inconsistent and overly cautious.
News FDA maps new regulatory route for ultra-rare diseases The FDA has sketched out its 'plausible mechanism' regulatory pathway for individualised therapies that treat ultra-rare diseases.
News Makary says FDA will "end two-trial dogma" for approvals The FDA plans to adopt a new policy that will do away with the default requirement to base regulatory filings for new medicines on two pivotal trials.
News Lilly's 'triple G' retatrutide aces crucial obesity trial Lilly's retatrutide achieved weight loss of more than 30% at two years in a new trial, firming up its credentials as a next-generation obesity drug.
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