Sarepta FDA Shipment Request - Search News

News

FDA asks Sarepta to stop shipping gene therapy

Reuters on MSN · 3d

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

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

Becker's Hospital Review · 6m

Sarepta reverses course, halts gene therapy shipments following FDA request

Sarepta will stop shipping its Duchenne muscular dystrophy gene therapy Elevidys following ongoing discussions with the FDA over safety labeling. The drugmaker said the pause, effective July 22, will allow time to respond to FDA inquiries and complete the agency’s safety labeling supplement process,

BioPharma Dive · 20h

FDA asks Sarepta to stop shipping Duchenne gene therapy

The company refused the FDA’s request and will continue shipping its therapy, Elevidys, to Duchenne patients who can still walk. A pause on shipments to older, non-ambulatory patients remains in place.

23h

Sarepta Therapeutics stock sinks after FDA tells company to stop shipping its bestselling drug

Sarepta stock tanked Friday after a new patient death was uncovered, spurring an FDA request to halt shipments of an ...

1don MSN

Sarepta Therapeutics stock sinks further Tuesday after halting shipment of bestselling drug Elevidys

Sarepta Therapeutics' (SRPT) stock continued to sink Tuesday following a rough end to last week, including a previously ...

3d

Drugmaker Refuses F.D.A. Request to Pull Treatment Linked to Patient Deaths

The regulator had asked Sarepta Therapeutics to halt all shipments of its therapy, Elevidys, after three patients died from ...

Some results have been hidden because they may be inaccessible to you

Show inaccessible results