News

EconoTimes6h
FDA Probes Death of 8-Year-Old Linked to Sarepta’s Elevidys Gene Therapy
The U.S. Food and Drug Administration (FDA) is investigating the death of an eight-year-old boy who received Sarepta ...
FDA Probes Death of Boy in Brazil on Sarepta’s Elevidys
US regulators are investigating the death of an 8-year-old boy in Brazil who received Sarepta Therapeutics Inc.’s Elevidys.
Sarepta Therapeutics Provides Clarifying Statement on ELEVIDYS
Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today issued the ...
FDA probes death of patient on Sarepta's Elevidys, partner Roche says death unrelated to therapy
The patient with Duchenne muscular dystrophy, who died in Brazil, was treated with Elevidys but was not a participant in a ...
Sarepta falls as FDA plans to investigate death of child who received 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 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 ...
The Prototype: Bringing Advanced Semiconductor Manufacturing Back To The U.S.
In this week’s edition of The Prototype, we look at a quantum computing milestone for biotech, a new way to get forever ...
BioWorld12h
CHMP rejects Sarepta’s Elevidys, changes mind on Lilly’s Kisunla
After a tough few weeks for Sarepta Therapeutics Inc., the EMA dealt another blow on July 25, announcing it will not be ...
FDA chief talks staffing, abortion drug and tobacco
The FDA is still on track to meet its user fee targets despite a higher-than-normal vacancy rate among scientific reviewers.
Medscape16h
EMA Says No to Duchenne Gene TherapyElevidys
The European drug authority recommends refusal of marketing authorization after study shows no benefit over placebo.
Precision Medicine Online16h
EMA's CHMP Recommends Against Approval for Sarepta, Roche Duchenne Gene Therapy Elevidys
Elevidys, which is also facing regulatory hurdles in the US, was developed by Sarepta Therapeutics but is sold by Roche outside of the US.
Applied Clinical Trials Online16h
FDA Crackdown on Trial Design: What July’s CRLs to Replimune and Capricor Mean for Sponsors
Complete Response Letters recently issued by the FDA signal heightened scrutiny of trial design and reinforce the agency’s shifting regulatory expectations for sponsors and CROs.