fda sarepta - Search News

Order byBest matchMost fresh

FDA asks Sarepta to stop shipping gene therapy

Exclusive: Sarepta says it won't comply with FDA request to stop shipping gene therapy Elevidys

U.S. regulators asked Sarepta Therapeutics (SRPT.O) on Friday to voluntarily halt shipments of its Elevidys gene therapy after a muscular dystrophy patient who received a different, experimental trea...

· 2h

Gene therapy maker Sarepta tells FDA it won’t halt shipments despite patient deaths

· 1d

FDA to ask Sarepta to stop shipping Duchenne gene therapy

· 1d

Sarepta shares slump on reports of third patient death this year

On Wednesday, Sarepta announced a restructuring plan that included 500 job cuts and halting development of several gene therapies for limb-girdle muscular dystrophy.

STAT · 21h

Sarepta Therapeutics crisis is huge blow to Duchenne families, company

· 1d

Sarepta plunges after third patient death tied to gene therapy - report

Hoodline7h

Sarepta Therapeutics Announces Layoff of 493 Employees, Including 80 in Ohio, Amid FDA Scrutiny and Stock Decline

Sarepta Therapeutics lays off 493 workers amid FDA probe, stock drop, and concerns over its gene therapy treatment, Elevidys.

1don MSN

Sarepta Shares Crash on Report That FDA Will Ask It to Stop Shipping Key Drug

The drop comes the day after the drugmaker said it would add a so-called black-box warning to its gene therapy Elevidys after two teenage boys receiving the treatment died earlier this year.

1don MSN

Sarepta shares plunge 40% as future of its gene therapy appears at risk

Shares of Sarepta Therapeutics plunged more than 30% on Friday as the future of its key gene therapy treatment appeared at risk. The Food and Drug Administration will request that the company voluntarily stop all shipments of the treatment, Elevidys, a person familiar with the matter told CNBC.