Sarepta Therapeutics Inc. (NASDAQ:SRPT) is one of the best low priced pharma stocks to buy now. Towards the end of June, ...

Del-zota is designed for patients with mutations amenable to exon 44 skipping, which is just 7% of the overall DMD patient ...

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.

The U.S. Food and Drug Administration has declined to approve Capricor Therapeutics' cell therapy for a heart condition, the ...

The company said it was “surprised” by the decision, which followed the ouster of cell and gene therapy officials from the ...

A journey through the FDA’s newly released complete response letters gave glimpses into the journeys to market for Eli ...

The FDA told Capricor in a letter that it is unable to approve its application for Deramiocel in its current form as it does ...

The FDA has rejected Capricor Therapeutics’ filing for approval of a Duchenne muscular dystrophy (DMD) cell therapy, raising ...

In its complete response letter, the FDA cited insufficient evidence establish deramiocel's effectiveness for cardiomyopathy associated with Duchenne muscular dystrophy. The decision comes after CBER ...

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.

The FDA rejected a Duchenne muscular dystrophy cell therapy from Capricor Therapeutics, as a larger study of the treatment ...