News

GSK Shares Drop After FDA Committee Vote Leaves Cancer-Drug Comeback in Doubt
GSK shares fell after a Food and Drug Administration advisory committee voted against approval of the company's Blenrep drug, a setback for its bid to reintroduce the blood-cancer treatment in the U.S ...
CNBCTV181h
Stock Crash: MNC drugmaker shares tank after key drug fails to get regulatory panel nod
According to reports, the USFDA's Oncologic Advisory Committee voted that the risks from the drug, called Blenrep, outweighed ...
Fierce Pharma2d
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 votes against overall benefit/risk profile of GSK's multiple myeloma candidate at proposed dosage
Drugmaker GSK said on Friday that the US Food and Drug Administration's Oncologic Drugs Advisory Committee had voted against ...
Pharmaceutical Technology1h
FDA approves GSK’s prefilled syringe presentation of Shingrix
The FDA has approved GSK's Shingrix vaccine (recombinant zoster vaccine or RZV) in a prefilled syringe presentation to prevent shingles.
NDTV Profit8h
GSK Blood Cancer Drug Blenrep Fails To Win FDA Panel Support
GSK remains confident in Blenrep’s safety and efficacy, and will work with the FDA as it reviews the drug, the company said ...
Asianet Newsable on MSN5h
GSK’s Blenrep Underwhelms FDA Panel Over Dose Risk-Benefit Balance In Myeloma; Retail Traders Stay Optimistic
The median progression-free survival was 32.6 months on the Blenrep combo compared to 12.5 months on the alternative. While ...
BioWorld11h
Blenrep misstep? ODAC cites tox, GSK dosing neglect in MM
The rough ride presaged by briefing documents came to pass for GSK plc with the drug first approved by the U.S. FDA as Blenrep (belantamab mafodotin, bel-maf), as the agency’s Oncologic Drugs Advisory ...