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The U.S. Food and Drug Administration has declined to approve Capricor Therapeutics' cell therapy for a heart condition and ...
Detailed price information for Sarepta Therapeutics (SRPT-Q) from The Globe and Mail including charting and trades.
A journey through the FDA’s newly released complete response letters gave glimpses into the journeys to market for Eli ...
In its complete response letter, the FDA cited insufficient evidence establish deramiocel's effectiveness for cardiomyopathy ...
The company said it was “surprised” by the decision, which followed the ouster of multiple cell and gene therapy officials from the agency during deramiocel’s review.
TAS-205 showed no significant impact on motor function in patients with Duchenne muscular dystrophy (DMD), highlighting the ongoing search for effective treatments for the rare condition.
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Asianet Newsable on MSNCapricor Stock Plunges Pre-Market After US FDA Declines Approval For Muscular Disorder TherapyThe FDA told Capricor in a letter that it is unable to approve its application for Deramiocel in its current form as it does ...
Solid Biosciences' DMD gene therapy shows promise with SGT-003 and strong cash backing through 2027. Click here to read an ...
The company said it was optimistic that the issues identified by the Food and Drug Administration could be resolved with new data.
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