elevidys fda - Search News

Order byBest matchMost fresh

Sarepta, FDA and gene

Sarepta shares slide again as drugmaker bows to FDA pressure to pause gene therapy

Shares of drugmaker Sarepta Therapeutics continued to sink Tuesday after the company said it would comply with a Food and Drug Administration request to pause shipments of its gene therapy following s...

· 3d · on MSN

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

· 6h

Sarepta Reverses Course, Pauses Elevidys Shipments Amid FDA Safety Review

· 6h

Sarepta Faces Fresh Setback. Why Now’s Not the Time to Buy the Stock.

Sarepta Therapeutics was falling again in premarket trading Tuesday as its future looks increasingly shaky after it agreed to halt shipments of its Elevidys drug under pressure from the Food and Drug ...

STAT · 10h

In surprise reversal, Sarepta Therapeutics says it will pause shipments of Duchenne gene therapy

STAT · 1d

Pharmalittle: We’re reading about Sarepta resisting FDA over Elevidys, agency naming top drug regulator, and more

STAT36m

Sarepta Therapeutics’ Duchenne therapy faces ‘arduous’ path back to market, senior FDA official says

Sarepta Therapeutics faces an "arduous path” to try to get its gene therapy for Duchenne muscular dystrophy back onto the market, a senior FDA official told STAT.

BioSpace7h

Sarepta Concedes to FDA Request, Suspends US Shipments of Elevidys

After initially refusing to suspend Elevidys distribution after two deaths, Sarepta has now given in to the FDA’s request, noting the need to maintain a good working relationship with the regulator.

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 unrelated drug.

1don MSN

Sarepta extends losses premarket after refusing FDA’s halt request

Sarepta Therapeutics (SRPT) shares fell as much as 4.8% in premarket trading Monday, poised to extend losses for a second session after plunging 36% on Friday.