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 Administration (FDA) has granted approval for HYMPAVZI ... Read More
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 the European Medicines Agency’s (EMA) Committee for ... Read More
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
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 to Pfizer's lung cancer drug, Vizimpro (dacomitinib), ... Read More
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 the European Commission's recent approval of Hulio ... Read More