United States — Food and Drug Administration & AstraZeneca

United States — Food and Drug Administration: The United States — Food and Drug Administration approved Trastuzumab deruxtecan for two new breast cancer indications, enabling its use in neoadjuvant and adjuvant settings.

AstraZeneca: AstraZeneca jointly developed and commercialized Trastuzumab deruxtecan with Daiichi Sankyo. The new approvals trigger milestone payments from AstraZeneca to Daiichi Sankyo and reinforce Trastuzumab deruxtecan's role in breast cancer treatment.

United States — Food and Drug Administration: The United States — Food and Drug Administration granted approval for Trastuzumab deruxtecan for new indications in HER2-positive early breast cancer, enabling its broader use in the United States.

AstraZeneca: AstraZeneca, in collaboration with Daiichi Sankyo, received FDA approval for Trastuzumab deruxtecan for new breast cancer indications, which is a significant positive development for the company's product portfolio and revenue.

United States — Food and Drug Administration: The United States — Food and Drug Administration is undergoing a significant shake-up with the departure of key officials like Tracy Beth Høeg and Marty Makary, and the United States — White House exerting more control over its policies.

AstraZeneca: AstraZeneca is mentioned as one of the companies whose approved protective RSV treatments for infants faced safety questions initiated by Tracy Beth Høeg.