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The U.S. Food and Drug Administration said on Friday it was investigating the death of an eight-year-old boy who received ...
The U.S. Food and Drug Administration said on Friday that it is investigating the death of an 8-year-old boy who received Elevidys, a Sarepta Therapeutics ( NASDAQ: SRPT) gene therapy for Duchenne ...
Sarepta Therapeutics failed to win the European drug regulator's backing for its muscle disorder gene therapy on Friday, as ...
Sarepta Therapeutics'SRPT brutal week continued Friday after European officials rejected the company's controversial gene therapy, Elevidys.The rejection, which was delivered to European partner ...
Elevidys, which is also facing regulatory hurdles in the US, was developed by Sarepta Therapeutics but is sold by Roche outside of the US.
The European Union’s health regulatory agency did not endorse approving Elevidys for ambulatory patients with Duchenne ...
Sarepta Therapeutics Inc. shares plunged after European regulators rejected its gene therapy Elevidys, intensifying scrutiny on the drugmaker after it was pressured to halt shipments of its treatment ...
Sarepta Therapeutics Inc. (NASDAQ:SRPT) stock declined 13% Friday after European regulators recommended against approving Elevidys, the company’s gene therapy for Duchenne muscular dystrophy.