Tag Archives: Shingrix

GSK Announces EMA Review of Prefilled Syringe Presentation for Shingrix Vaccine

(IN BRIEF) GSK has announced that the European Medicines Agency (EMA) has accepted its regulatory application for a prefilled syringe presentation of Shingrix, its recombinant zoster vaccine (RZV) for preventing shingles. This new presentation simplifies administration for healthcare providers by … Read the full press release

GSK Announces FDA Review of Convenient Prefilled Syringe for Shingrix Shingles Vaccine

(IN BRIEF) GSK has announced that the FDA has accepted its application to review a prefilled syringe version of Shingrix, its shingles vaccine. This new version, expected to be available from January 2025, eliminates the need for reconstitution, offering a … Read the full press release

GSK: US FDA VRBPAC’s vote brings us one step closer to approval of Shingrix

LONDON, 14-Sep-2017 — /EuropaWire/ — GlaxoSmithKline plc [LSE/NYSE: GSK] announced today that the Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the US Food and Drug Administration (FDA) voted unanimously that the data support the efficacy and safety of Shingrix … Read the full press release