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Drugmaker GSK said on Friday that the US Food and Drug Administration's Oncologic Drugs Advisory Committee had voted against ...
GSK’s attempt to relaunch Blenrep was blocked by FDA advisers due to poor clinical benefit, safety concerns, and eye-related side effects.
The FDA has declined to approve Columvi, in combination with the chemo regimen GemOx, for the treatment of second-line DLBCL ...
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 ...
FDA head Marty Makary said the agency may fast-track drugs from companies that “equalize” the cost of medicines between the U ...
"GSK remains confident in the benefit/risk profile of Blenrep and will continue to work closely with the FDA as they complete their review for Blenrep in patients with relapsed or refractory multiple ...
Sino Biopharma will acquire LaNova Medicines, which has licensed cancer drugs for Merck and AstraZeneca, for $951 million.
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 ...
The FDA on Tuesday rejected a skin therapy from Replimune Group, suggesting a hardened stance on drug approvals under new agency officials ...
The FDA cited manufacturing issues but did not flag problems with Ultragenyx’s data package for UX111, with the biotech ...
GSK (GSK) stock slips as FDA advisors vote against the approval of a combination regimen involving thecompany's blood cancer drug Blenrep. Read more here.
The British pharmaceutical company said combinations for its Blenrep drug were evaluated in adults with relapsed or refractory multiple myeloma who have previously received at least one line of ...