News

FDA probes death of patient on Sarepta's Elevidys, partner Roche says death unrelated to therapy
The U.S. Food and Drug Administration said on Friday it was investigating the death of an eight-year-old boy who received ...
Investor's Business Daily on MSN4d
Sarepta's 'Unprecedented Times' Continue As Company Rebukes The FDA
Sarepta stock took another dive Monday after the biotech company refused the FDA's request to voluntarily stop all shipments ...
Sarepta Faces Regulatory Showdown As Analysts Cut Price Targets
Sarepta faces FDA scrutiny over Elevidys as analysts downgrade stock and warn of long-term debt risks amid market uncertainty.
Managed Healthcare Executive6d
FDA Wants Elevidys Off the Market. Sarepta Said No.
Elevidys is a gene therapy approved to treat Duchenne muscular dystrophy. Last month, Sarapta halted sales of the therapy for non-ambulatory patients.
FierceBiotech9y
The FDA updates expanded access drug rules, and Sarepta plunges
The FDA has come up with a series of ... some added regulatory context on troublesome issues like the added threat of adverse ... before green-lighting the drug. But with Sarepta, ...
Yahoo8y
FDA confirms that critic of Sarepta drug has left the agency - Yahoo
An FDA spokeswoman would not say when Farkas left, and whether his departure is tied to the review for the Sarepta drug is not known. Farkas could not be reached for comment. But he has played a ...