AstraZeneca has gained European Union approval for its new breast cancer drug camizestrant (branded as Etcamah), to be used in combination with a CDK4/6 inhibitor for certain adults with advanced, ER-positive, HER2-negative breast cancer with ESR1 mutations. The EU nod follows earlier approvals in Japan, the UAE, and Saudi Arabia, while the U.S. FDA review is still ongoing. Meanwhile, China’s drug regulator has become the first in the world to approve Takeda’s novel narcolepsy therapy TAK-861, a selective orexin 2 receptor agonist for narcolepsy type 1, ahead of decisions in the U.S., Europe, and Japan, marking a historic milestone for China’s regulatory system and global drug development.
Sources:
Китай первым в мире одобрил инновационный препарат TAK-861 ...
AstraZeneca Wins EU Approval for Breast-Cancer Drug as U.S. Review Continues
Astra Breast Cancer Drug Gets EU Nod After FDA ...
EU regulator backs approval for AstraZeneca's ...
AstraZeneca drug wins EU backing for breast cancer
AstraZeneca Wins EU Approval for Breast-Cancer Drug as ...
‘Historic breakthrough’: China approves novel drug ahead of US, Japan and Europe
AstraZeneca (AZN) Receives EU Approval Recommendation for Camize
Europe Approves AstraZeneca's Camizestrant After FDA Advisory ...