Sarepta FDA Gene Therapy Issues - Search News

Order byBest matchMost fresh

News

Sarepta, FDA and gene therapy

BioPharma Dive · 4d

5 questions on Sarepta, the FDA and a Duchenne gene therapy crisis

While Sarepta has now consented to the FDA’s request to stop selling Elevidys, the company’s brief standoff with the agency could still carry major consequences for the Duchenne community.

Continue reading

· 3d · on MSN

Sarepta shares slide again as drugmaker bows to FDA pressure to pause gene therapy

Sarepta Gets Thumbs Down From Regulators Regarding Elevidys Gene Therapy

11hon MSN

Sarepta fails to win EU backing for muscle disorder gene therapy

Sarepta Therapeutics suffered another major setback on Friday as Europe's drug regulator decided not to recommend the ...

3don MSN

Sarepta Therapeutics laying off dozens in Ohio, won't comply with FDA request to halt therapy

After the FDA request, Cambridge, Massachusetts-based Sarepta said in a statement that it will continue to ship the therapy ...

Fierce Biotech4d

Sarepta LGMD trials all hit by FDA hold amid newly surfaced safety concerns over gene therapy

The Sarepta saga continues, with the FDA slapping a clinical hold across all of the company’s investigational limb-girdle ...

Patient dies in Sarepta gene therapy trial, adding to safety concerns

A 51-year-old man died last month after receiving an experimental treatment from Sarepta, the third death this year tied to ...

Some results have been hidden because they may be inaccessible to you

Show inaccessible results