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- FDA seeks external input on rare disease trial criteria and endpoint selectionThe FDA announced it will seek additional external feedback as it reviews how to evaluate efficacy and safety data for rare disease therapies. The agency noted the difficulty of setting appropriat…
- GSK reports 94% response rate for Jideytro in ROS1-positive lung cancer at World ConferenceGSK is moving a newly acquired lung-cancer drug, Jideytro, toward FDA review after presenting data at the World Conference on Lung Cancer. The conference data showed a 94% response rate when Jidey…