News FDA won’t approve Lilly’s mirikizumab for ulcerative colitis The FDA has issued a complete response letter to Eli Lilly, turning down its attempt to get approval for anti-IL-23p19 antibody mirikizumab as a treatment for ulcerative c
News FDA advisors split on Biogen’s ALS therapy But unanimous vote on biomarker validity could support accelerated approval of tofersen.
News MHRA unveils big shakeup in UK clinical trials regs Reforms will make applications streamlined and flexible without affecting safety, says agency.
News GSK wins the vote contest in FDA’s RSV vaccine panels Advisory committee votes unanimously that RSVPreF3 shot is effective, and 10-2 on safety.
News Pfizer’s RSV shot clears FDA adcomm; now it’s GSK’s turn There was debate about cases of Guillain Barré and the population of the phase 3 RENOIR trial.
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 Ipsen' Bylvay fluffs its lines in biliary atresia trial Ipsen's IBAT inhibitor Bylvay has failed a trial in biliary atresia, a rare and serious liver disease that affects babies and has limited treatments.
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