EU
EU Regulator Determines Mounjaro Effective for Sleep Apnea, No Separate Approval Required
Mounjaro, sleep apnea, EU regulator, European Medicines Agency (EMA), tirzepatide, weight loss, obesity
Novo Holdings Receives Unconditional EU Approval for $16.5 Billion Acquisition of Catalent
Novo Holdings, Catalent, European Commission, Acquisition, EU Approval, Pharmaceutical Services
Pfizer’s Breakthrough Hemophilia Drug Hympavzi Wins EU Approval
Pfizer, Hympavzi, EU approval, hemophilia A, hemophilia B, marstacimab, once-weekly subcutaneous treatment, pre-filled auto-injector pen
EU Regulators Schedule December 6 Decision on Novo Holdings’ Acquisition of Catalent
EU regulators, Novo Holdings, Catalent, acquisition, antitrust review, December 6 deadline
Astellas’ Vyloy (Zolbetuximab) Receives EU Approval for Advanced Gastric and Gastroesophageal Junction Cancer Treatment
Astellas, Vyloy, Zolbetuximab, EU Approval, Gastric Cancer, Gastroesophageal Junction Cancer, Claudin 18.2, Targeted Therapy
Merck’s WINREVAIR Receives EU Approval for Pulmonary Arterial Hypertension Treatment
WINREVAIR, Merck, EU Approval, Pulmonary Arterial Hypertension, PAH Treatment
Regeneron Secures EU Approval for Lymphoma Treatment Ordspono Following FDA Rejection
Regeneron, EU approval, lymphoma, bispecific antibody, odronextamab, Ordspono, FDA rejection
AstraZeneca Secures Landmark EU Approval for Imfinzi-Lynparza Combo in Endometrial Cancer Treatment
AstraZeneca, Imfinzi, Lynparza, endometrial cancer, EU approval, combination therapy, immunotherapy, PARP inhibitor, mismatch repair proficient, mismatch repair deficient
EU Panel Recommends Wegovy for Preventing Cardiac Events, Following FDA Lead
Wegovy, EU panel, FDA, cardiac events, weight loss, Novo Nordisk
EU Calls for Cooperation and Increased Manufacturing to Overcome GLP-1 Shortage
GLP-1 receptor agonists, EU, shortages, diabetes, weight management, manufacturing, cooperation, regulatory actions