Drug Approval | March 31, 2026
ENHERTU approved in China as first HER2-targeted ADC for early breast cancer
The decision is based on the phase 3 DESTINY-Breast11 trial
The decision is based on the phase 3 DESTINY-Breast11 trial
The Phase 1 study, a non-randomised, open-label, multicentre trial, is evaluating IKS014 in patients with locally advanced or metastatic solid tumours expressing HER2
The approval follows results from the DESTINY-Breast06 phase 3 trial, which showed ENHERTU significantly extended progression-free survival compared to chemotherapy
The trial will evaluate safety endpoints including dose-limiting toxicities and adverse events
Syngene International has reported total income of Rs. 926 crore during the period ended September 30, 2025
The Fast Track Designation was supported by nonclinical data as well as clinical results from the ongoing Phase I/IIa trial evaluating the safety and tolerability
The new cGMP-compliant HPAPI Laboratory is equipped with state-of-the-art isolators designed to meet Occupational Exposure Band 5 (OEB-5) requirements
Facility marks cornerstone of $50 billion investment in medicines R&D and manufacturing in America
Datroway becomes the first and only therapy to show overall survival benefit versus chemotherapy in this difficult-to-treat patient population
Second positive Phase III trial of AstraZeneca and Daiichi Sankyo’s Enhertu in HER2-positive early breast cancer reinforces its potential to become a foundational treatment option in curative-intent setting
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