FDA Gene Therapy Concerns

News

FDA, Sarepta and Death Of

FDA launches probe into new Elevidys death as Sarepta, Roche stress gene therapy not at fault

In its own communique issued shortly after the FDA’s, Sarepta elaborated on the situation and confirmed a Roche statement to Bloomberg News that linked the probe to a fatality in Brazil and held that the death of the patient was unrelated to Elevidys itself.

· 2d

FDA opens probe into mysterious death linked to gene therapy

· 13h

FDA Probes Death Of 8-Year-Old Who Received Sarepta's Elevidys

MIT Technology Review3d

The deadly saga of the controversial gene therapy Elevidys

The drug, which was designed to treat Duchenne muscular dystrophy, has been linked to the deaths of two teenage boys.

Fierce Biotech7d

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 ...

STAT4d

For many Duchenne families, halt to gene therapy is heartbreak upon heartbreak

As gene therapy maker Sarepta Therapeutics tangles with FDA over its Duchenne treatment, patients and their families are ...

14d

FDA Delays Approval For Ultragenyx's Gene Therapy, But Not A Dealbreaker, Says Analyst

Ultragenyx's UX111 gene therapy faces FDA delay due to facility issues; analysts adjust price targets amid uncertain ...

17don MSN

US FDA declines to approve Ultragenyx's gene therapy for rare genetic disorder

The U.S. Food and Drug Administration has declined to approve Ultragenyx Pharmaceutical's experimental gene therapy to treat a rare inherited disorder, citing manufacturing concerns, the company said ...

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

Show inaccessible results