News

STAT12h
Replimune skin cancer therapy rejected by FDA, a sign of regulators’ hardened stance
The FDA on Tuesday rejected a skin therapy from Replimune Group, suggesting a hardened stance on drug approvals under new agency officials ...
MedPage Today1d
Drugmaker Refuses FDA's Request to Pull Gene Therapy Tied to Patient Deaths
The agency also revoked Sarepta's platform technology designation for AAVrh74 Friday and issued a safety communication saying ...
BioPharma Dive1d
5 questions on Sarepta, the FDA and a Duchenne gene therapy crisis
A standoff over Elevidys could have major consequences for Duchenne patients, gene therapy companies and the perception of ...
Fierce Biotech1d
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 ...
Fierce Pharma1d
Lundbeck, Otsuka's PTSD bid for Rexulti dealt a setback at FDA advisory committee
The prospect of Lundbeck and Otsuka’s Rexulti becoming part of a new treatment for post-traumatic stress disorder (PTSD) ...
Becker's Hospital Review1d
Cuts to NIH, FDA could slash drug approvals: 5 notes
An analysis from the Congressional Budget Office warns that cuts to the National Institutes of Health and FDA drug reviews could significantly reduce the number of new medications reaching the U.S.
BioSpace1d
Lack of US Data Stymie Roche’s Earlier-Stage Lymphoma Push for Columvi
Roche and Genentech were unable to sufficiently demonstrate the benefit of using Columvi in an earlier treatment setting for ...
Axios on MSN1d
Drugmaker refuses FDA request to pull gene therapy
An unusual public feud between the Food and Drug Administration and a maker of gene therapies for rare diseases could test ...
FDA Suspends Muscular Dystrophy Drug After 3 Patient Deaths
The U.S. Food and Drug Administration ( FDA) has placed an immediate clinical hold on Sarepta Therapeutics' investigational ...
Gene therapy maker Sarepta tells FDA it won’t halt shipments despite patient deaths
Drugmaker Sarepta Therapeutics says it won’t comply with a request from U.S. regulators to halt all shipments of its gene ...
STAT4d
Sarepta Therapeutics crisis is huge blow to Duchenne families, company
The FDA will request Sarepta Therapeutics stop all shipments of Elevidys, its gene therapy for Duchenne muscular dystrophy, ...
US FDA advisers recommend against Otsuka's PTSD combination treatment
The U.S. Food and Drug Administration's panel of independent advisers on Friday voted against the efficacy of Otsuka Pharma's ...