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FDA grants priority review to Enhertu for high-risk early breast cancer

AstraZeneca (NASDAQ:AZN) and Daiichi Sankyo moved a step closer to a major label expansion for their blockbuster cancer therapy, Enhertu, after the U.S. FDA fast-tracked an application to treat patients with early-stage breast cancer at high risk of recurrence.

Leia mais: FDA grants priority review to Enhertu for high-risk early breast cancer
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Adial Pharmaceuticals narrows 2025 loss, clears regulatory hurdles for AD04

Adial Pharmaceuticals (NASDAQ:ADIL) reported a significant reduction in annual net losses for 2025, as the clinical-stage biotech firm secures FDA alignment and strategic partnerships to transition its lead alcohol-use disorder candidate into Phase 3 trials.

Leia mais: Adial Pharmaceuticals narrows 2025 loss, clears regulatory hurdles for AD04
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Halozyme partner J&J wins FDA nod for myeloma combo featuring ENHANZE tech

Halozyme Therapeutics (NASDAQ:HALO) shares were in focus Friday after partner Johnson & Johnson secured U.S. regulatory approval for a subcutaneous combination therapy that significantly reduces the risk of disease progression in patients with relapsed multiple myeloma.

Leia mais: Halozyme partner J&J wins FDA nod for myeloma combo featuring ENHANZE tech
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PMV Pharmaceuticals secures orphan drug status as ovarian cancer data strengthens

PMV Pharmaceuticals (NASDAQ:PMVP) reported significant clinical momentum for its lead candidate, rezatapopt, bolstered by a fresh FDA Orphan Drug Designation and clinical results showing high response rates in late-stage ovarian cancer patients.

Leia mais: PMV Pharmaceuticals secures orphan drug status as ovarian cancer data strengthens