regulatory approval

News

Merus has its first approval for a commercial product, getting the go-ahead from the FDA for Bizengri, a first-in-class therapy for cancer

News

Kelun-Biotech has become the second drugmaker to bring a TROP2 ADC to regulatory approval, after its sac-TMT drug was cleared in China

News

Novartis' fast-growing breast cancer drug gets another growth driver as EU approves adjuvant use in patients with early-stage HR+, HER2- tumours

News

BridgeBio grabs FDA approval for its ATTR cardiomyopathy drug Attruby, setting up a challenge to market leader Pfizer

News

Jazz Pharma has claimed FDA approval for its HER2-directed bispecific antibody Ziihera as a treatment for biliary tract cancer

News

Eisai has launched its new therapy for biliary tract cancer (BTC) Tasfygo in Japan, the first world market for the FGFR-targeting drug