Trending in Oncology: FDA Full Approval for BRAFTOVI and more

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This edition highlights major regulatory actions across oncology and biopharma, including full FDA approval of the BRAFTOVI combination in first-line BRAF V600E-mutant metastatic colorectal cancer and FDA acceptance of the NDA for giredestrant in ESR1-mutated advanced breast cancer. Additional updates cover dosing optimizations in EGFR-mutated non-small cell lung cancer, EMA validation for ENHERTU in early HER2-positive breast cancer, Fast Track designation in recurrent high-grade glioma, and Japan’s approval of Alpha DaRT in unresectable head and neck cancer.
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Oncology
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