AstraZeneca PLC, AZN, AZN.L, ZEG.DE, AZN.ST, FDA Calendar, PDUFA Date

Company Name	AstraZeneca PLC AZN, AZN.L, ZEG.DE, AZN.ST
Drug Name	ENHERTU (sBLA)
Event Name	FDA decision on ENHERTU followed by paclitaxel, trastuzumab and pertuzumab for the neoadjuvant treatment of adult patients with HER2 positive breast cancer
Event Date	05/18/2026
Outcome Date	05/16/2026
Outcome	FDA approved ENHERTU in the neoadjuvant and adjuvant settings of patients with HER2 positive early breast cancer on May 16, 2026
Drug Status
Rival Drugs
Market Potential
Other Approvals	Enhertu is now approved for nine indications with six across both early and metastatic HER2 positive breast cancer
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