FDA again rais­es doubts on Stealth's ul­tra-rare dis­ease drug ahead of ad­comm

Da­ta sub­mit­ted to the FDA by Stealth Bio­Ther­a­peu­tics for its ul­tra-rare dis­ease drug like­ly aren’t suf­fi­cient for an ap­proval or even an ac­cel­er­at­ed ap­proval, agency …

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