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- FDA finds Capricor's Duchenne stem cell therapy failed to meet Phase 3 goals, contradicting company claimsThe U.S. Food and Drug Administration announced that the stem cell treatment from Capricor Therapeutics did not achieve the primary objectives in its Phase 3 trial for Duchenne muscular dystrophy.…
- FDA finds Replimune's melanoma data package uninterpretable, foreshadows tough advisory committee reviewThe FDA has deemed the single-arm mid-stage study submitted by Replimune for its oncolytic immunotherapy RP1 as not interpretable, raising concerns ahead of an upcoming advisory committee meeting.…