Brief: EMA Says Valneva's Chikungunya Vaccine Receives Positive CHMP Opinion

Eckert & Ziegler SE

31/05/2024 11:37

May 31 (Reuters) - EMA:
    * EMA SAYS IXCHIQ (CHIKUNGUNYA VACCINE (LIVE)) RECEIVED
POSITIVE
CHMP OPINION
    * EMA:CHMP GAVE RECOMMENDATION FOR CONDITIONAL MARKETING
AUTHORISATION FOR DURVEQTIX(FIDANACOGENE ELAPARVOVEC), GENE
THERAPY TREATMENT FOR HAEMOPHILIA
    * EMA SAYS CHMP HAS RESTARTED EVALUATION OF AN APPLICATION
TO
RENEW CONDITIONAL MARKETING AUTHORISATION FOR TRANSLARNA
(ATALUREN)
    * EMA SAYS CHMP GAVE POSITIVE OPINION FOR GALLIAPHARM , TO
BE USED
FOR RADIOLABELLING OF VARIOUS KITS USED FOR POSITRON EMISSION
TOMOGRAPHY IMAGING
    * EMA SAYS CHMP ADOPTED POSITIVE OPINION FOR CEJEMLY
(SUGEMALIMAB)
FOR TREATMENT OF ADULTS WITH METASTATIC NON-SMALL-CELL LUNG
CANCER
    * EMA SAYS CHMP RECOMMENDED GRANTING A MARKETING
AUTHORISATION
UNDER EXCEPTIONAL CIRCUMSTANCES FOR ADZYNMA
    * EMA:CHMP RECOMMENDS GRANTING MARKETING AUTHORISATION FOR
ZEGALOGUE FOR TREATMENT OF SEVERE HYPOGLYCAEMIA WITH DIABETES
MELLITUS
    * EMA SAYS CHMP RECOMMENDED EXTENSIONS OF INDICATION FOR
DUPIXENT
THATS ALREADY AUTHORISED IN EU
    * EMA SAYS CHMP ADOPTED POSITIVE OPINION RECOMMENDING CHANGE
TO
TERMS OF MARKETING AUTHORISATION FOR MEDICINAL PRODUCT DUPIXENT

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