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Innovative Drug HER2 ADC Rejected for Marketing, Stricter FDA Review May be Normal in the Future
June 06, 2023The FDA's rejection of the marketing of SYD985 is just the beginning, and with the rising enthusiasm for the R&D of ADCs, the standards of subsequent review by the FDA of the popular target ADCs will be inevitably raised. -
AstraZeneca and Daiichi's HER2 ADC hits goal in pivotal trial
May 12, 2019AstraZeneca and Daiichi Sankyo’s HER2-targeting antibody drug conjugate (ADC) has hit the primary endpoint in a pivotal phase 2 trial, teeing the partners up to file for FDA approval in the first half of the fiscal year.
Pharma Sources Insight January 2025
