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deramiocel · news · pharmadog

← back to deramiocel

News mentioning deramiocel

37 stories

10dUS senators grill FDA nominee Overton on ability to ‘stand up’ to Trumpbiospace

14dMikhail, Davis on board with regulatory framework tailored to rare disease therapiesbiospace

Sep 3, 26Capricor, Replimune illustrate why FDA must listen to rare disease specialistsbiospace

Aug 26, 26Capricor’s DMD therapy still alive, Merck/Moderna’s cancer vax shines, FDA’s future revealedbiospace

Aug 25, 26Capricor secures reprieve as FDA extends DMD cell therapy reviewfiercebiotech

Aug 24, 26FDA extends review of Capricor cell therapy; Pain drug startup to go publicbiopharma dive

Aug 24, 26Capricor’s Duchenne therapy has new life after FDA grants 3-month extensionbiospace

Aug 24, 26FDA delays Capricor's deramiocel PDUFA date to review new dataendpoints

Aug 24, 26Capricor, Replimune reviews signal FDA’s return to reliability but every application will stand alonebiospace

Aug 21, 26Capricor investor calls for change as company awaits decision on Duchenne candidatebiospace

Aug 20, 26STAT+: Capricor Therapeutics’ Duchenne treatment is heading for an FDA rejectionstat

Aug 20, 26Opinion: Capricor’s Duchenne muscular dystrophy drug and the countless tiny decisions that can make or break a studystat

Aug 14, 26Capricor soars on potential FDA review extension, filing amendmentsbiospace

Aug 14, 26Capricor shares spike on CEO comments; Cytokinetics sues Bristol Myersbiopharma dive

Aug 14, 26Capricor soars on plan to amend DMD filing after adcomm setbackfiercebiotech

Aug 6, 26Third time’s the charm for Replimune as melanoma drug earns FDA greenlightbiospace

Aug 5, 26Chaotic adcomms threaten to derail FDA’s bid to renew trust after Makary, Prasadbiospace

Aug 5, 26Rumors of biggest pharma merger ever drop amid Q2 earnings, contentious FDA adcommsbiospace

Jul 31, 26Capricor CEO won’t rule out legal action against FDA after negative adcommbiospace

Jul 31, 26UniQure welcomes possible adcomm for Huntington’s asset as regulatory ‘jitters’ spread through biopharmabiospace

Jul 30, 26Replimune overcomes ‘messy data’ to secure positive adcomm vote for melanoma therapybiospace

Jul 29, 26FDA advisers vote against approval of Capricor’s DMD therapy in chaotic adcomm meetingbiospace

Jul 29, 26FDA reviewers vote against approval of Capricor’s DMD therapy in chaotic adcomm meetingbiospace

Jul 29, 26Capricor Duchenne cell therapy voted down by FDA panelbiopharma dive

Jul 29, 26Updated: FDA adcomm votes down Capricor's DMD therapy over efficacyendpoints

Jul 29, 26FDA adcomm shoots down Capricor's Duchenne cell therapy after meeting marked by statistical disputefiercebiotech

Jul 29, 26STAT+: FDA expert panel recommends against approval of Capricor’s Duchenne drugstat

Jul 28, 26STAT+: Pharmalittle: We’re reading about FDA views on a Duchenne drug, GSK cost savings, and morestat

Jul 28, 26FDA says Replimune’s melanoma data package is ‘not interpretable,’ setting up tough adcommbiospace

Jul 27, 26UPDATE: FDA disputes Capricor's claims of Phase 3 success for DMD cell therapybiospace

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