News FDA kicks off review of Roche's Gazyva for wider lupus use Roche could be just months away from an FDA approval of Gazyva as the first anti-CD20 therapy for systemic lupus erythematosus.
News Trump signs order to hasten psychedelic medicine access Donald Trump has signed an executive order directing the FDA to reduce regulatory hurdles that stand in the way of bringing psychedelics to patients.
News UK says it has hit target on commercial trial set-up times The UK has made progress in its efforts to slash set-up times for clinical trials, one of the factors blamed for a decline in industry-backed studies.
News FDA accelerated approval path needs improvement, says ICER The FDA's accelerated approval route has delivered important new drugs to patients quicker, but is opaque and plagued by inconsistencies, says ICER.
News FDA renews criticism of trial sponsors over transparency The FDA has launched a drive to get clinical trial sponsors to disclose the results of studies – even if they are negative.
News FDA hands another rejection to Replimune's melanoma therapy Replimune has had its advanced melanoma treatment RP1 turned down by the FDA for a second time, prompting job losses.
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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