regulatory approval

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Kelun's MSD-partnered TROP2 drug gets first okay in China

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

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Kisqali gets early breast cancer approval in Europe

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

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BridgeBio poised to challenge Pfizer after Attruby approval

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

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Jazz gets first FDA nod for HER2 bispecific Ziihera

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

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Eisai debuts biliary tract cancer drug in Japan

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

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AbbVie bags EU nod for key drug from ImmunoGen takeover

AbbVie's $10.1 billion takeover of ImmunoGen has been rewarded with EU approval for Elahere, the first drug specifically cleared for folate receptor-alpha (FRα) positive, platinum-resistant

Kelun's MSD-partnered TROP2 drug gets first okay in China

Kisqali gets early breast cancer approval in Europe

BridgeBio poised to challenge Pfizer after Attruby approval

Jazz gets first FDA nod for HER2 bispecific Ziihera

Eisai debuts biliary tract cancer drug in Japan

AbbVie bags EU nod for key drug from ImmunoGen takeover

Lily gets FDA nod for SERD-CDK 4/6 combo in breast cancer

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regulatory approval

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