GlobalData on MSN5d
CHMP recommends AbbVie’s Rinvoq be approved for adult GCA
The treatment has gained approval in the European Union (EU) for a range of conditions, including psoriatic arthritis, ...
PMLiVE1d
J&J receives three CHMP recommendations for immunology and oncology indications
Tremfya, Stelara and Darzalex have been recommended for ulcerative colitis, Crohn’s disease and multiple myeloma, ...
Novartis Gets CHMP Opinion for Label Expansion of Fabhalta
The CHMP recommends granting a marketing authorization to NVS' Fabhalta for the treatment of adults with C3 glomerulopathy, an ultra-rare, progressive kidney disease with no currently approved ...
PMLiVE2d
Rare diseases: CHMP recommends Krystal’s Vyjuvek for dystrophic epidermolysis bullosa
The European Medicines Agency’s (EMA) human medicines committee has recommended Krystal Biotech’s Vyjuvek (beremagene ...
BioSpace2d
Biogen, Eisai Continue Leqembi’s European Rally as CHMP Reaffirms Positive Opinion
Leqembi’s application now moves forward to the European Commission, which will issue a formal verdict for the injection that ...
FiercePharma5d
CHMP again backs Leqembi amid flurry of approval recommendations
Following a flurry of activity at this month’s meeting of the European Medicines Agency’s Committee for Medicinal Products ...
Valneva Receives EMA’s Positive CHMP Opinion for Adolescent Label Extension for Chikungunya Vaccine IXCHIQ®
If granted, IXCHIQ® will become the first vaccine against the chikungunya virus (CHIKV) available in the EU for adolescents 12 years of age and ...
Biogen, Eisai announces CHMP of EMA reaffirmed positive opinion of lecanemab
Eisai (ESAIY) and Biogen (BIIB) announced that the Committee for Medicinal Products for Human Use, CHMP, of the European Medicines Agency, EMA, ...
The Pharma Letter4d
Three novel medicines recommended for approval by EMA/CHMP
The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended three novel medicines for approval at its ...
Biogen, Eisai: CHMP Reaffirms Backing of Leqembi Alzheimer's Drug
Biogen and Eisai said the European Medicines Agency's Committee for Medicinal Products for Human Use has reaffirmed its recommended approval of their Alzheimer's drug Leqembi.
Regeneron Gets CHMP Backing of Linvoseltamab in Multiple Myeloma
Regeneron on Friday said the recommendation covers adults with adults with relapsed and refractory multiple myeloma who have received at least three prior therapies, including a proteasome inhibitor, ...