sarepta therapeutics fda

Order byBest matchMost fresh

Sarepta, FDA

Sarepta Therapeutics’ stock slips further as company bows to FDA pressure to halt shipments

Sarepta Therapeutics shares were lower in premarket trading on Tuesday, as the drugmaker relented to a Food and Drug Administration request to halt shipments of a gene therapy.

· 3h

Sarepta Therapeutics stock tumbles on concern about FDA study requirements

· 2d · on MSN

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

· 1d

InnovationRx: Sarepta Blinks In Showdown With FDA

The latest twist in the saga followed a decision by Children’s Hospital Los Angeles to halt use of the drug while it was facing regulatory uncertainty.

STAT · 2d

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

· 1d

Sarepta pares gains as report suggests an ‘arduous’ path for Duchenne drug

Fierce Pharma24m

FDA weighs new study requirements for Sarepta to confirm safety of gene therapy Elevidys: report

Sarepta would need to conduct new analyses to validate the safety of Elevidys—which has had U.S. shipments paused by the company over a mounting string of controversies—to the FDA, Endpoints News reported Thursday, citing an unnamed senior FDA official.

Investor's Business Daily on MSN38m

The Hits Keep Coming For Sarepta. Why Its Latest Setback Creates A 'Dangerous Precedent' For Gene Therapies.

Sarepta stock plunged again Thursday on a report that the Food and Drug Administration will require additional clinical testing to validate the safety profile of its controversial gene therapy, Elevidys.

22hon MSN

Sarepta Needs to Show FDA Elevidys Won’t Cause More Deaths

The Food and Drug Administration won’t sign off on Sarepta Therapeutics Inc. bringing its controversial gene therapy back to the market until the company can persuade US regulators that it won’t cause more deaths,

STAT1d

Pharmalittle: We’re reading about Sarepta’s ‘arduous’ path ahead, pharma’s reliance on China, and more

Sarepta faces an “arduous and treacherous path” to try to get its Duchenne muscular dystrophy therapy Elevidys back onto the market

2don MSN

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

Sarepta stock fell after it agreed to voluntarily halt shipments of its experimental medicine Elevidys for Duchenne muscular dystrophy following a request from the FDA.