The firm will share new overall survival data from the INAVO120 trial with regulators to support the breast cancer drug's approval.

The U.S. Food and Drug Administration (FDA) recently issued two new guidance documents governing details of the Accelerated Approval ...

Shares of Sarepta (SRPT) are down this morning, potentially due to the latest FDA Adverse Event Reporting System update on Elevidys, which ...

RBC Capital analyst Brian Abrahams says shares of Sarepta (SRPT) could be trading lower today on an FDA database update that included am ...

In year two of the trial, Elevidys demonstrated statistically significant and clinically improvements across three key ...

The positive results from the second part of the EMBARK trial contrast with findings from one-year post treatment, which did ...

The gene therapy improved motor functions in children with Duchenne muscular dystrophy two years after treatment ...

Riding recent momentum in the Duchenne muscular dystrophy space, Capricor Therapeutics, Wave Life Sciences, Regenxbio and ...

While the last decade has brought considerable progress for patients with DMD, substantial unmet need remains. Several ...

It will grow to $XX million in 2029 at a compound annual growth rate (CAGR) of XX%.” - The Business Research Company LONDON, GREATER LONDON, UNITED KINGDOM, January ...

Despite mixed results using gene therapies to treat Duchenne muscular dystrophy, drug developers are pushing ahead with the belief the answer could come down to delivery.

C&EN’s tabulation follows approvals from the FDA’s Center for Drug Evaluation and Research; therefore, it does not include blood products, gene therapies, vaccines, and other therapies that ...