News

Castle Biosciences, Revolution Medicines get FDA breakthrough statuses
Castle Biosciences' DecisionDx-Melanoma test and Revolution Medicines' elironrasib cancer drug receive FDA Breakthrough Designations. Read more here.
STAT1d
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
While Sarepta has now consented to the FDA’s request to stop selling Elevidys, the company’s brief standoff with the agency ...
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 Review2d
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.
BioSpace2d
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 ...
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 ...
Fierce Pharma4d
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 ...
FDA Advisory Panel Votes Against Approval of GSK's Blenrep Combo
GSK plc GSK announced that the FDA’s Oncologic Drugs Advisory Committee (ODAC) has voted against the overall benefit/risk profile of the Blenrep (belantamab mafodotin-blmf) combination therapy at the ...
Investomania5d
GSK Blindsided as Blenrep Stumbles Again in the US, Shares Dive
GSK shares sink after FDA panel rejects Blenrep cancer drug, raising doubts over turnaround strategy. GSK (LSE: GSK) investors took a sharp knock on Friday after its much-hyped blood cancer drug, ...