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The company said it was optimistic that the issues identified by the Food and Drug Administration could be resolved with new data.
A journey through the FDA’s newly released complete response letters gave glimpses into the journeys to market for Eli ...
The company said it was “surprised” by the decision, which followed the ouster of cell and gene therapy officials from the ...
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 ...
Capricor Therapeutics (CAPR) on Friday said the U.S. Food and Drug Administration (FDA) has refused to approve its lead cell ...
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 ...
Sarepta is facing a shareholder lawsuit over ELEVIDYS-related deaths. Robbins LLP cites safety risks and stock losses.