EU
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
FDA Delays Dupixent Decision for Uncontrolled COPD Treatment, EU Panel Recommends Approval
Dupixent, dupilumab, COPD, FDA, EU approval, Sanofi, Regeneron, uncontrolled COPD, treatment delay
EU Upholds Approval of PTC Therapeutics’ Duchenne Muscular Dystrophy Treatment
EU, PTC Therapeutics, Duchenne Muscular Dystrophy (DMD), treatment, approval, rejection, committee.
Translarna by PTC Therapeutics: Awaiting Another EU Regulatory Review for Muscular Dystrophy Treatment
PTC Therapeutics, Translarna, muscular dystrophy, EU review, regulatory approval, Duchenne muscular dystrophy (DMD), European Medicines Agency (EMA), ataluren, rare disease treatment.