The U.S. Food and Drug Administration is tightening restrictions on a gene therapy used to treat Duchenne muscular dystrophy ...

The US FDA has tightened the use of a Duchenne muscular dystrophy gene therapy after two teenage patients died from acute ...

Fred Hutch bioengineer Dr. Matthias Stephan is working to develop a special foam that could help make gene therapy for blood ...

FDA added a boxed warning to Elevidys after two pediatric deaths and imposed stricter monitoring rules. ・Use of gene therapy ...

Through substantial leadership turnover and workforce cuts, the FDA has continued to support the advanced therapy sector, ...

Earlier this year, researchers at Children's Hospital of Philadelphia and Penn created a first-of-its-kind drug customized to ...

Sarepta must also run a post-marketing study for Elevidys to better assess the risk of serious liver injury in patients dosed ...

The Food and Drug Administration is adding a new warning to a gene therapy linked to two patient deaths earlier this year.

MONDAY, Nov. 17, 2025 (HealthDay News) — The U.S. Food and Drug Administration (FDA) is tightening restrictions on a gene ...

Sharonville, Ohio, celebrates the opening of the new Cincinnati Children's Applied Gene and Cell Therapy Center.

Krystal Biotech drives Vyjuvek growth, premium margins, global expansion, a $1B goal, and pipeline data ahead with a $219.50 ...