Browsing Tag
CHMP
21 posts
FDA approves Pfizer’s HYMPAVZI for breakthrough hemophilia treatment
In a major leap for hemophilia patients, Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug…
Dr. Reddy’s Laboratories secures key European endorsement for Rituximab biosimilar
In a significant development for the pharmaceutical industry, Dr. Reddy’s Laboratories Ltd. has received a positive opinion from…
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…
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…
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…
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…
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…
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,…
Pfizer’s Vizimpro receives EMA approval recommendation for NSCLC treatment
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has given a significant boost…
Mylan launches Hulio, a biosimilar to Humira, across major European markets
Mylan has officially launched Hulio, its biosimilar to AbbVie’s Humira (adalimumab), across major European markets. This launch follows…