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deramiocel · news · pharmadog

← back to deramiocel

News mentioning deramiocel

27 stories

20hSTAT+: Capricor Therapeutics’ Duchenne treatment is heading for an FDA rejectionstat

22hOpinion: Capricor’s Duchenne muscular dystrophy drug and the countless tiny decisions that can make or break a studystat

6dCapricor soars on potential FDA review extension, filing amendmentsbiospace

6dCapricor shares spike on CEO comments; Cytokinetics sues Bristol Myersbiopharma dive

6dCapricor soars on plan to amend DMD filing after adcomm setbackfiercebiotech

14dThird time’s the charm for Replimune as melanoma drug earns FDA greenlightbiospace

15dChaotic adcomms threaten to derail FDA’s bid to renew trust after Makary, Prasadbiospace

15dRumors of biggest pharma merger ever drop amid Q2 earnings, contentious FDA adcommsbiospace

20dCapricor CEO won’t rule out legal action against FDA after negative adcommbiospace

20dUniQure welcomes possible adcomm for Huntington’s asset as regulatory ‘jitters’ spread through biopharmabiospace

21dReplimune overcomes ‘messy data’ to secure positive adcomm vote for melanoma therapybiospace

22dFDA advisers vote against approval of Capricor’s DMD therapy in chaotic adcomm meetingbiospace

22dFDA reviewers vote against approval of Capricor’s DMD therapy in chaotic adcomm meetingbiospace

22dCapricor Duchenne cell therapy voted down by FDA panelbiopharma dive

22dUpdated: FDA adcomm votes down Capricor's DMD therapy over efficacyendpoints

22dFDA adcomm shoots down Capricor's Duchenne cell therapy after meeting marked by statistical disputefiercebiotech

22dSTAT+: FDA expert panel recommends against approval of Capricor’s Duchenne drugstat

23dSTAT+: Pharmalittle: We’re reading about FDA views on a Duchenne drug, GSK cost savings, and morestat

23dFDA says Replimune’s melanoma data package is ‘not interpretable,’ setting up tough adcommbiospace

24dUPDATE: FDA disputes Capricor's claims of Phase 3 success for DMD cell therapybiospace

24dFDA scientists question Capricor data; Legend CEO steps downbiopharma dive

24dSTAT+: Ahead of hearing, FDA questions the efficacy of Capricor’s Duchenne drugstat

25dFDA has recommitted to adcomms—but to what end?biospace

May 11, 26Inhibrx delivers ‘differentiated’ cancer drug data; Fractyl starts diabetes gene therapy trialbiopharma dive

May 8, 26STAT+: Capricor Therapeutics accuses Nippon Shinyaku of slow-walking plans on Duchenne drugstat

May 8, 26STAT+: The biotech news you need to read todaystat

May 8, 26Capricor sues Nippon Shinyaku over Duchenne drug 'pricing flaw' and launch prependpoints