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

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 ...

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

Capricor Therapeutics (CAPR) on Friday said the U.S. Food and Drug Administration (FDA) has refused to approve its lead cell ...

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.

Taiho Pharmaceutical’s investigational Duchenne muscular dystrophy (DMD) therapy, pizuglanstat, has shown no benefit in a Phase III trial.

Taiho Pharmaceutical has suffered a blow to its near-term pipeline after a drug candidate for Duchenne muscular dystrophy ...

Households incur substantial costs to accommodate Duchenne muscular dystrophy (DMD) patients, according to a survey of U.S.

About Robbins LLP : A recognized leader in shareholder rights litigation, the attorneys and staff of Robbins LL have been dedicated to helping shareholders recover losses, improve corporate governance ...

Bernstein Liebhard LLP, a nationally acclaimed investor rights law firm, reminds Sarepta Therapeutics, Inc. (“Sarepta” or the “Company”) (NASDAQ: SRPT) investors of ...

Wolf Haldenstein Adler Freeman & Herz LLP announces that a class action lawsuit has been filed in the U.S. District Court for ...