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

Solid Biosciences' DMD gene therapy shows promise with SGT-003 and strong cash backing through 2027. Click here to read an ...

In its complete response letter, the FDA cited insufficient evidence establish deramiocel's effectiveness for cardiomyopathy ...

Teijin Automotive Technologies North America has rebranded as CSP following its acquisition by Aurelius Private Equity. The ...

As part of its transition to a standalone, privately held business, Teijin Automotive Technologies North America has changed ...

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 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.

Mr. Mahatme brings decades of experience in strategic finance, capital formation, and operational leadership to support company's transformation and growth in autoimmune disease CAMBRIDGE, Mass., July ...

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

Morgan Riddle’s effect on Wimbledon semifinalist Taylor Fritz’s rise in the rankings has been significant. He says so himself ...

The company said it was optimistic that the issues identified by the Food and Drug Administration could be resolved with new data.