Fierce Pharma Asia—Astellas' first-in-class FDA nod; Otsuka's IgAN win; Samsung Bio's $1.2B contract
By: Angus Liu
Astellas' first-in-class CLDN18.2 drug Vyloy has cleared the FDA. After a positive phase 3 readout, Otsuka is targeting an accelerated approval filing for a kidney disease candidate.