资讯

Sarepta Soars After FDA Says Some Patients Can Get Elevidys
Sarepta Therapeutics Inc. shares rose sharply early Tuesday after US regulators reversed course and recommended that patients ...
Sarepta will resume gene therapy shipments after FDA review of recent patient death
Shares of drugmaker Sarepta Therapeutics surged in afterhours trading Monday after the company said it would resume shipping ...
Sarepta Therapeutics stock sinks after FDA tells company to stop shipping its bestselling drug
Sarepta Therapeutics' (SRPT) stock continued to sink Monday, down about 5% in early trade, following a rough end to last week, including a previously unreported patient death in a clinical trial of an ...
Sarepta Therapeutics stock sinks further Tuesday after halting shipment of bestselling drug ...
Sarepta stock tanked Friday after a new patient death was uncovered, spurring an FDA request to halt shipments of an ...
STAT14 天
Sarepta Therapeutics’ Duchenne therapy faces ‘arduous’ path back to market, senior ...
Sarepta Therapeutics faces an "arduous path” to try to get its gene therapy for Duchenne muscular dystrophy back onto the ...
The American Journal of Managed Care6 天
FDA Recommends Sarepta Resume DMD Gene Therapy Shipments for Ambulatory Patients
Shipment of delandistrogene moxeparvovec, a gene therapy for Duchenne muscular dystrophy (DMD), will resume following a ...
FDA Probes Death Of 8-Year-Old Who Received Sarepta's Elevidys
The U.S. Food and Drug Administration (FDA) announced on Friday, after market close, that it is investigating the death of an ...
BioPharma Dive8 天
FDA allows Sarepta to resume some Elevidys shipments
Wall Street analysts suggested the FDA’s unexpected change in stance might reflect pressure from advocacy groups and a rebuke ...
BioSpace8 天
FDA Does 180 on Sarepta, Freeing DMD Gene Therapy for Ambulatory Patients
The swift FDA action removes an overhang from Sarepta and allows Elevidys to return to the market without another safety ...
Fierce Pharma7 天
Vinay Prasad departs FDA amid conservative criticism, controversy over Sarepta gene therapy
Vinay Prasad, M.D., has left the FDA less than three months into the role as director of the Center for Biologics Evaluation ...
Sarepta Therapeutics, Inc. (SRPT): “You Don’t Court Homicide,” Says Jim Cramer
We recently published 11 Stocks That Jim Cramer Recently Talked About. Sarepta Therapeutics, Inc. (NASDAQ:SRPT) is one of the ...
FDA probes death of patient on Sarepta's Elevidys, partner Roche says death unrelated to ...
The U.S. Food and Drug Administration said on Friday it was investigating the death of an eight-year-old boy who received ...