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GSK falls as blood cancer drug likely headed for US rejection
GSK shares fell more than 6% on Friday to the bottom of Britain's blue-chip index after a U.S. FDA advisory panel recommended ...
GSK shares fall after blood cancer drug likely headed for U.S. rejection
(Reuters) -GSK shares fell more than 6% on Friday after a U.S. FDA advisory panel recommended against approving its blood ...
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 ...
Fierce Pharma7d
As GSK eyes Blenrep's US return, FDA flags eye safety concerns ahead of advisory committee meeting
GSK has been enjoying regulatory momentum in recent months as it works to bring its antibody-drug conjugate (ADC) Blenrep ...
FDA flags safety concerns related to GSK’s blood cancer drug ahead of AdCom meeting
GSK (GSK) stock in focus as the FDA staff raise safety concerns over Blenrep combo for multiple myeloma ahead of an AdCom ...
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 ...
GSK Shares Drop After FDA Committee Vote Leaves Cancer-Drug Comeback in Doubt
The pharmaceutical company said it remained confident in the benefit and risk profile of Blenrep and will continue to work ...
STAT20h
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 ...
FDA advisers vote against combination therapies of GSK's blood cancer drug
The U.S. Food and Drug Administration's panel of independent advisers voted on Thursday against approval of GSK's blood ...
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 ...
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 ...
Insider Monkey24d
GSK (GSK) Gains FDA Approval for Benlysta Autoinjector for Lupus Treatment
On June 24, the company announced receipt of FDA approval for a 200 mg/mL autoinjector of Benlysta (belimumab) for the treatment of active lupus nephritis (LN).