News

Sarepta will resume gene therapy shipments after FDA review of recent patient death

Shares of beleaguered drugmaker Sarepta Therapeutics jumped in afterhours trading Monday after the company said it would ...
Fierce Pharma5d

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 ...
BioSpace5d

Sarepta Denies Latest Patient Death is Elevidys-Linked as FDA Launches Probe

Brazilian authorities said the death was unlikely to have been caused by Elevidys and was instead more in line with severe ...
The Pharma Letter5d

Patient death in Brazil not related to Elevidys, Sarepta says

The US Food and Drug Administration (FDA) issued a press release late Friday announcing an investigation into the death of an ...

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

FDA probes Elevidys after an 8-year-old's death in Brazil; Sarepta and Roche say the death was unrelated to gene therapy ...
Fierce Pharma4d

FDA takes U-turn on Sarepta's Elevidys, backing Duchenne gene therapy again in ambulatory patients

Monday, the FDA said Sarepta may resume treating ambulatory DMD patients with Elevidys. The recommendation comes just 10 days ...
GEN - Genetic Engineering and Biotechnology News6d

FDA Probes Death of Brazilian Boy Linked to Sarepta’s Elevidys

The FDA is investigating the death last month of an eight-year-old boy in Brazil who had received Sarepta Therapeutics’ Elevidys® (delandistrogene moxeparvovec-rokl)—though the company and its ...
Stocktwits on MSN5d

Retail Bulls Stick With Sarepta After 8-Year-Old Patient’s Death Deemed Unrelated To DMD Gene Therapy

Retail sentiment around Sarepta Therapeutics remained upbeat on Monday after the company said Friday that the death of an ...
Becker's Hospital Review4d

Death of 8-year-old not tied to Sarepta gene therapy: FDA

The FDA has reported that the recent death of an 8-year-old boy was unrelated to Sarepta Therapeutics’ gene therapy Elevidys and recommended lifting the voluntary hold on the treatment, which is used ...
TipRanks on MSN5d

Sarepta says eight-year-old death deemed unrelated to Elevidys

Just before 6:00 p.m. ET today, the U.S. Food and Drug Administration issued a press release announcing an investigation into the death of an eight-year-old Duchenne muscular dystrophy patient who had ...
Precision Medicine Online6d

FDA Investigating Death of Boy in Brazil Treated With Sarepta's Duchenne Gene Therapy

Sarepta maintains it reported the incident to the FDA in June, and the boy's doctor had deemed his death was unrelated to treatment.

FDA recommends lifting voluntary hold on Elevidys in ambulatory patients

FDA recommends lifting the hold on Sarepta's gene therapy Elevidys for ambulatory patients after investigation; ...