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Shortly after the U.S. FDA announced an investigation into the death of a patient who had received Elevidys, a gene therapy ...
Intel (NASDAQ: INTC) stock slumped 8% after the chipmaker forecast steeper losses than expected in the third quarter and announced plans to slash jobs, reducing headcount to 75,000 by the end of year, ...
The European drug authority recommends refusal of marketing authorization after study shows no benefit over placebo.
(Reuters) -The U.S. Food and Drug Administration said on Friday it was investigating the death of an eight-year-old boy who ...
The Revell family hoped a gene therapy could buy time for their sons, who have a rare and fatal disease. After two patients died, the drug’s manufacturer halted dosing under pressure from the FDA.
Roche provides regulatory update on Elevidys™ gene therapy for Duchenne muscular dystrophy in the EU
BASEL, Switzerland I July 25, 2025 I Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the ...
The U.S. Food and Drug Administration (FDA) is investigating the death of an eight-year-old boy who received Sarepta ...
US regulators are investigating the death of an 8-year-old boy in Brazil who received Sarepta Therapeutics Inc.’s Elevidys.
Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today issued the ...
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 ...
Genetic testing could not confirm Duchenne muscular dystrophy, but a muscle biopsy at UCLA did. "He could see that he was ...
Sarepta Therapeutics suffered another major setback on Friday as Europe's drug regulator decided not to recommend the ...
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