CHMP Recommends Granting Conditional Marketing Authorisation For Kayshild
Jan 30 (Reuters) - EMA's CHMP:
STARTED A REVIEW OF TAVNEOS FOLLOWING EMERGING INFORMATION THAT RAISES QUESTIONS REGARDING THE DATA INTEGRITY OF THE ADVOCATE STUDY
RECOMMENDED GRANTING A CONDITIONAL MARKETING AUTHORISATION FOR KAYSHILD (SEMAGLUTIDE)
RECOMMENDS EXTENSION OF THERAPEUTIC INDICATION FOR IMFINZI
RECOMMENDS GRANTING MARKETING AUTHORISATION FOR SUPEMTEK
RECOMMENDS GRANTING CONDITIONAL MARKETING AUTHORISATION FOR REZUROCK FOLLOWING RE-EXAMINATION
FINALISED ASSESSMENT OF APPLICATION TO EXTEND USE OF MOUNJARO
EXTEND USE OF MOUNJARO TO INCLUDE TREATMENT OF SYMPTOMATIC LONG-TERM HEART FAILURE WITH PRESERVED EJECTION FRACTION IN OBESE ADULTS
DID NOT RECOMMEND SEPARATE INDICATION SHOULD BE GRANTED FOR TREATMENT OF HFPEF, AGREED TO INCLUDE RELEVANT DATA FROM STUDY
Further company coverage: [NOVOb.CO]
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