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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.
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 suffered another major setback on Friday as Europe's drug regulator decided not to recommend the ...
After a tough few weeks for Sarepta Therapeutics Inc., the EMA dealt another blow on July 25, announcing it will not be ...
Elevidys, which is also facing regulatory hurdles in the US, was developed by Sarepta Therapeutics but is sold by Roche outside of the US.
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Pharmaceutical Technology on MSNCHMP rejects Elevidys in latest setback for Sarepta
In the latest of a string of issues Sarepta has faced, the CHMP said it was recommending against approval as the pivotal ...
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