The approval positions Amgen’s Bkemv (formerly ABBP 959) as a key competitor to complement C5 inhibitor Soliris (eculizumab), which contributed $3.1 billion in global revenues to AZ last year.

An antibody-drug conjugate (ADC) that GSK licensed from China's Hansoh Pharma in a $1.7 billion deal last year has been given breakthrough status by the FDA. The coveted designation for GSK5764227 ...