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First gene-editing treatment for sickle cell patients gets US approval

First gene-editing treatment for sickle cell patients gets US approval
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United statesNicole verdunDrug administrationCentre for biologics evaluationOffice of therapeutic productsUnited states foodTherapeutic productsBiologics evaluationAfrican americans

World s first chikungunya vaccine approved by USFDA | World s first chikungunya vaccine approved by USFDA

The vaccine, called Ixchiq, developed by French biotech company Valneva, is approved for individuals 18 years of age and older, who are at increased risk of exposure to chikungunya virus.

United statesPeter marksCentre for biologics evaluationDrug administrationBiologics evaluationNorth americaSoutheast asia

FDA approves new Covid boosters as cases rise around US

Hospitalisations from Covid-19 have crept up in recent weeks, although the rise is lower than the same time last year

New yorkUnited statesLos angelesAssociated pressCentre for biologics evaluationDrug administrationDisease controlBiologics evaluationGuardian news

FDA approves updated Covid-19 vaccines against the circulating variants

FDA approves updated Covid-19 vaccines against the circulating variants
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United statesLori tremmel freemanPeter marksBiontech covidDan barouchCity health officialsCentre for virologyCentre for biologics evaluationAdvisory committee on immunization practicesVaccine researchDrug administrationAdvisory committeeImmunization practicesDisease controlBiologics evaluationExecutive director

Effective Quality CDMO Contracting

Effective Quality CDMO Contracting
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United statesPaulj cummingsCentre for veterinary medicineCentre for biologics evaluationManufacturing organization marketUs department of healthEuropean pharmaceutical contract developmentPharma consulting ltdHuman services foodDrug administration centre for evaluationBig pharmaContract manufacturing arrangementsQuality agreementsProduct profileNorth americaTechnical agreement