News

BioPharma Dive43m
Replimune drug rejected by FDA; Omega raises $647M biotech fund
Analysts questioned whether the complete response letter Replimune received was evidence of changing approval standards at ...
STAT5h
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 ...
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 ...
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 ...
Healio3d
FDA rejects Genentech’s glofitamab-gxbm for DLBCL, stymied by insufficient evidence
The FDA issued a complete response letter to Genentech indicating it cannot approve the company’s biologic license ...
Fierce Pharma3d
FDA rejects Roche's Columvi in earlier diffuse large B-cell lymphoma, citing lackluster US data
The FDA has declined to approve Columvi, in combination with the chemo regimen GemOx, for the treatment of second-line DLBCL ...