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Enhertu’s market conquest is continuing apace. | Already tracking at $5 billion in annual sales, Enhertu has secured two new FDA approvals to treat early breast cancer. But while arriving nearly two months early, the adjuvant label comes with a catch.
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The FDA has approved Daiichi Sankyo and AstraZeneca’s Enhertu for two new indications in HER2-positive early breast cancer.

New trastuzumab deruxtecan indications cover neoadjuvant and adjuvant treatment

Welcome to Fierce Pharma's regulatory tracker for the first half of 2026. | In this tracker, Fierce Pharma is recording the…

With the help of DNA testing company Natera and its personalized molecular residual disease (MRD) blood test Signatera, Roche’s…

After an impressive phase 3 showing last fall, AstraZeneca’s wager on CinCor Pharma and its aldosterone synthase inhibitor (ASI)…

Over the last 18 months, Merck and Kelun-Biotech have notched four approvals in China for their TROP2-directed antibody-drug…