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 (marstacimab-hncq) to prevent or reduce bleeding episodes in individuals aged 12 and above with hemophilia A or B without inhibitors. This marks a groundbreaking advancement in the treatment landscape for […]
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 Medicinal Products for Human Use (CHMP) regarding its proposed biosimilar, DRL_RI, also known as ITUXREDI. This endorsement could pave the way for the launch of this promising biosimilar across European […]
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 lung cancer (NSCLC). Specifically designed for tumors with an activating HER2 (ERBB2) mutation, the drug aims to fill a significant gap in systemic therapy options following platinum-based chemotherapy. Enhertu’s EU […]
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 vaccine aims to protect infants through maternal immunization and individuals 60 years and older against lower respiratory tract disease (LRTD) caused by RSV. ABRYSVO Offers Dual Protection Against Severe RSV […]
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 pan-Janus kinase (JAK) inhibitor, this cream is specifically designed for adult patients battling moderate to severe chronic hand eczema (CHE). This validation kicks off the official review process by the […]
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 Disease has obtained approval for expanded use in the European Union (EU). The approval allows the treatment of gMG in children and adolescents aged six to 17 years who are […]
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 tislelizumab. This treatment is intended for adult patients suffering from unresectable, locally advanced, or metastatic esophageal squamous cell carcinoma (ESCC) who have previously undergone platinum-based chemotherapy. “Tislelizumab is the first […]
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 antagonist from Merck, also known as MSD outside the United States and Canada. The drug is being developed for adults with refractory or unexplained chronic cough. The European Commission (EC) […]
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), recommending its approval as a first-line treatment for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). This recommendation specifically targets patients with epidermal growth factor receptor […]
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 for all indications of the reference product. Hulio will be accessible to patients in Europe as soon as possible, thanks to a partnership between Mylan and Fujifilm Kyowa Kirin Biologics. […]