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Pharmabiz20m
US FDA approves GSK’s Shingrix in a prefilled syringe presentation for prevention of shingles
GSK plc announced that the US Food and Drug Administration (FDA) has approved a prefilled syringe presentation of Shingrix (GSK’s Recombinant Zoster Vaccine or RZV) for the prevention of ...
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 ...
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 ...
Pharmaceutical Technology52m
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.
GSK seeks FDA nod for expanded use of RSV vaccine in adults
British drugmaker GSK said on Monday it had submitted an application to the U.S. Food and Drug Administration to extend the ...