Efgartigimod Shows Promise in Immune Checkpoint Inhibitor-Related Myasthenia Gravis–Myositis Overlap Syndrome

A newly reported case from Nanchang University suggests that efgartigimod, a neonatal Fc receptor (FcRn) blocker approved for generalized myasthenia gravis, may offer a promising treatment option for patients who…

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Pembrolizumab Outperforms Standard Chemotherapy in First-Line dMMR Endometrial Cancer Study

Merck has reported positive topline findings from the Phase 3 KEYNOTE-C93 trial, demonstrating that pembrolizumab (KEYTRUDA®) significantly extended progression-free survival (PFS) compared with standard platinum-based chemotherapy in patients with mismatch…

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Leadership Is More Than a Title

Editor's Note: This article was originally written and submitted to us by Regina Portnoy. When people think about leadership in clinical research, they often think about timelines, enrollment goals, budgets,…

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Huyabio’s HBI-8000 and Opdivo Combination Shows Significant Benefit in Phase 3 Melanoma Study

As reported on Fierce Pharma, Huyabio has reported encouraging Phase 3 results for its investigational oral HDAC inhibitor, HBI-8000, when used alongside Bristol Myers Squibb’s immunotherapy Opdivo (nivolumab) in patients…

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AtaiBeckley Completes Patient Dosing in Phase 2b Trial of VLS-01 for Treatment-Resistant Depression

As reported on PharmaBiz, AtaiBeckley has announced a key milestone in the development of its investigational depression therapy, VLS-01, with the final participant now dosed in the company’s Phase 2b…

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FDA Issues Complete Response Letter for Rivoceranib–Camrelizumab Combination in Advanced Liver Cancer

As reported by The Manila Times, the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Elevar Therapeutics regarding its new drug application for the…

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ISTH 2026: Long-Term Phase 3 Data Support Denecimig as a Flexible Prophylactic Option for Hemophilia A

As covered by Fairfax Times, Novo Nordisk has reported encouraging long-term findings for its investigational hemophilia A therapy denecimig (Mim8), with interim results from the Phase 3 FRONTIER4 extension study…

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FDA Grants Breakthrough Device Designation to Aurenar’s V-Link System for Preventing Cerebral Vasospasm After Brain Hemorrhage

As reported on MobiHealth News, the U.S. Food and Drug Administration (FDA) has awarded Breakthrough Device designation to Aurenar’s V-Link System, a noninvasive neuromodulation technology designed to help reduce cerebral…

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