Japan’s MHLW approves CSL Behring’s Andembry to stop HAE attacks
The decision is underpinned by safety and efficacy data from the international Phase III VANGUARD trial.
Approvals
FDA grants priority review for Boehringer’s zongertinib NDA in NSCLC
Cumberland’s Vibativ injection gains China’s NMPA approval
EC conditionally approves MSD’s Welireg for VHL disease and RCC
FDA grants fast track status to Rznomics’ RZ-001 for HCC
EC approves CSL’s Andembry to stop hereditary angioedema attacks
Health Canada approves Novartis’ Fabhalta for PNH with haemolytic anaemia
Lundbeck gains FDA fast track designation for MSA therapy amlenetug
