Tag: CHMP
AstraZeneca and Daiichi Sankyo’s Enhertu recommended for EU approval
AstraZeneca and Daiichi Sankyo's Enhertu has been recommended for approval in the European Union (EU) for the treatment of adult patients with advanced non-small cell ... Read More
EC approves Pfizer’s ABRYSVO RSV vaccine for infants and older adults
Pfizer Inc. announced that the European Commission (EC) has granted marketing authorization for ABRYSVO, its bivalent respiratory syncytial virus (RSV) prefusion F vaccine. This groundbreaking ... Read More
EMA validates LEO Pharma’s application for delgocitinib cream in chronic hand eczema
LEO Pharma A/S said that the European Medicines Agency (EMA) has validated its marketing authorization application (MAA) for delgocitinib cream. Touted as a groundbreaking topical ... Read More
Alexion’s Soliris approved for paediatric myasthenia gravis treatment in EU
Soliris (eculizumab), the first and only targeted therapy approved for the treatment of paediatric patients with refractory generalised myasthenia gravis (gMG), from Alexion, AstraZeneca Rare ... Read More
CHMP recommends approval for BeiGene’s tislelizumab in ESCC treatment
BeiGene, a global biotechnology firm, has revealed that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval for ... Read More
CHMP endorses Merck’s gefapixant for EU approval for chronic cough treatment
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval for gefapixant, an investigational, non-narcotic, oral selective P2X3 receptor ... Read More