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    • Menveo

Menveo Newsletter
  • GSK's Meningococcal Vaccine Approved for Regulatory Review 19 Apr 2024 09:57 GMT

    … US Food and Drug Administration (FDA) has accepted for …  (Meningococcal Group B Vaccine) and Menveo (Meningococcal [Groups A … life-threatening complications. Despite treatment, among those who … trial, all primary endpoints were achieved for the MenABCWY vaccine …

  • FDA Approves GSK's BLA for 5-in-1 Meningococcal Vaccine 16 Apr 2024 23:24 GMT

    … Bexsero (Meningococcal Group B Vaccine) and Menveo (Meningococcal [Groups A, … of meningococcal immunization. The trial had approximately 3650 participants … do recover from bacterial meningitis. Those who do recover … 4,5 The potential FDA approval could help …

  • FDA accepts BLA for meningococcal ABCWY vaccine, target action date set 16 Apr 2024 20:38 GMT

    … review by the FDA, which assigned a Prescription Drug User Fee Action … -135 Oligosaccharide Diphtheria CRM197 Conjugate Vaccine (Menveo).1 The submission and acceptance … -us-fda/ Meningococcal ABCWY vaccine meets primary endpoints in phase 3 trial …

  • FDA accepts GSK’s pentavalent meningococcal vaccine for review 16 Apr 2024 21:34 GMT

    … one pentavalent meningococcal vaccine made by Pfizer. The FDA will review GSK … existing meningococcal vaccines: Bexsero, a meningococcal group B vaccine; and Menveo, which covers … to phase 3 trial results published last year, the vaccine candidate elicited …

  • GSK's Meningococcal ABCWY Vaccine Candidate Coming in 2025 16 Apr 2024 16:11 GMT

    … vaccines with demonstrated efficacy and safety profiles, Bexsero® (MenB-4C) and Menveo … these U.S. FDA-approved vaccines with fewer … S., while meningococcal vaccine recommendations for all … are various approved meningococcal vaccines and candidates conducting …

  • GSK 5-in-1 Meningococcal Vaccine Given a PDUFA 16 Apr 2024 15:52 GMT

    … profiles, Bexsero (Meningococcal Group B Vaccine) and Menveo (Meningococcal [Groups A, C … it.4,5 The potential FDA approval could help impact this … -endpoints-meningococcal-abcwy-vaccine-for-phase-3-trial 3. Bacterial Meningitis. CDC. Accessed …

  • GSK trails after Pfizer in 5-in-1 meningococcal vaccine race 16 Apr 2024 14:33 GMT

    … vaccines Bexsero and Menveo and is designed to protect against meningitis … combination category after the FDA cleared the latter’s … confusion among consumers and doctors, leading to poor compliance … in a statement. “Despite treatment, among those who contract …

  • FDA Accepts Application for 5-in-1 Meningococcal Vaccine Candidate 16 Apr 2024 16:25 GMT

    … ABCWY vaccine candidate (GSK), assigning a Prescription Drug User … diphtheria CRM197 conjugate vaccine) (Menveo). The proposed vaccine candidate is intended … the phase 3 MenABCWY trial, which was a … complication, and despite treatment, approximately 1 in …

  • GSK meningococcal vaccine accepted by US FDA for review 16 Apr 2024 12:28 GMT

    … FTSE 100 pharmaceuticals giant said the Prescription Drug User Fee … established meningococcal vaccines - Bexsero and Menveo - both … -threatening complications. Despite treatment, the mortality rate … phase three trial of the MenABCWY vaccine candidate showed …

  • FDA Accepts GSK's 5-in-1 Meningococcal ABCWY Vaccine Candidate For Regulatory Review 16 Apr 2024 07:33 GMT

    … statement on Tuesday. The Prescription Drug User Fee Act or PDUFA … regulatory decision by the US FDA on this application is 14 … profiles, Bexsero and Menveo. GSK stated that the vaccine candidate provides broad …

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