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GSK s RSV vaccine for adults 50-59 at increased risk accepted by FDA for Priority Review

GSK plc's application to extend its RSV vaccine indication to adults aged 50-59 at risk has been accepted by the FDA for priority review. If approved, it would be the first vaccine for this population. The application is supported by positive phase III trial results.

Clin virolRichard osei yeboahDrug administrationCenters for diseasePrescription drug user fee actPriority review voucherBiologics license applicationClin infectClinical outcomesRespiratory syncytial virusProspective multicenterImmune responseVaccine against respiratory syncytial virus givenIncluding adultsIncreased riskOlder adults

GSK s RSV Vaccine, AREXVY, Accepted Under Priority Review in US for the Prevention of RSV Disease in Adults Aged 50-59 at Increased Risk -February 06, 2024 at 07:04 am EST

Application supported by positive results of a phase III trial showing immune response and acceptable tolerability profile in this population Adults aged 50 and above with underlying medical.

United kingdomUnited kingdom generalJ clin virolRichard osei yeboahSaponiqx incCenters for diseaseAgenus incAntigenics incDrug administrationPriority reviewRespiratory syncytial virus vaccinePriority review voucherBiologics license applicationPrescription drug user fee actSyncytial virus vaccineSafety information

GSK : Japan s Ministry of Health, Labour and Welfare accepts Arexvy regulatory application to prevent RSV disease in adults aged 50-59 at increased risk - Form 6-K -December 12, 2023 at 06:09 am EST

a3878w UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 6-K REPORT OF FOREIGN PRIVATE ISSUER.

United statesCity ofUnited kingdomUnited kingdom generalSteph mountifieldCamilla campbellJosh williamsTim foleyRichard osei yeboahSimon mooreJ clin virolJeff mclaughlinMick readeyNick stoneJames dodwellKathleen quinn

GSK s RSV vaccine Arexvy accepted for review by Japan s MHLW

GSK s RSV vaccine Arexvy accepted for review by Japan s MHLW
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J clin virolRichard osei yeboahCenters for diseaseJapan ministry of healthNew englj medDisease controlOlder adultsChronic medical conditions