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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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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
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CorMedix reverses 2024 loss as DefenCath sales and Melinta acquisition fuel growth

CorMedix (NASDAQ:CRMD) reported a significant return to profitability for the fourth quarter on Thursday, as the commercial rollout of its lead product, DefenCath, gained momentum alongside contributions from its newly acquired Melinta Therapeutics portfolio.

Leia mais: CorMedix reverses 2024 loss as DefenCath sales and Melinta acquisition fuel growth