CHMP Backs Datroway for First-Line Treatment of Metastatic Triple-Negative Breast Cancer in EU

As reported on Stock Titan, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Datroway® (datopotamab deruxtecan) as a…

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FDA Review Raises Questions About Replimune’s Melanoma Therapy Ahead of Advisory Committee Vote

As reported on Reuters, Replimune’s experimental cancer treatment RP1 is facing increased regulatory scrutiny after U.S. Food and Drug Administration (FDA) reviewers expressed concerns about whether current clinical data adequately…

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Alebund Initiates Global Phase IIb Trial of AP306 for Hyperphosphatemia in Hemodialysis Patients

As reported on PharmaBiz, Alebund Pharmaceuticals has announced the first patient has been enrolled and treated in a global Phase IIb clinical trial evaluating AP306, an investigational therapy for hyperphosphatemia…

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Affinia Therapeutics Secures FDA Orphan Drug Designation for Investigational BAG3 Cardiomyopathy Gene Therapy

As reported on Pharmaceutical Business Review, Affinia Therapeutics has been granted orphan drug designation by the US Food and Drug Administration (FDA) for AFTX-201, an experimental gene therapy being developed…

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Scientists Find Poly-coated Nanoparticles Plus Therapeutic Drugs Have a Potential as Cancer Treatment

As reported on Science Daily, scientists have combined polymer-coated nanoparticles with therapeutic drugs for cancer treatment, including treatment for ovarian cancer. The nanoparticles target tumors and subsequently release their payloads,…

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Cincinnati Children’s Becomes Seventh U.S. Center Authorized to Deliver ZEVASKYN for RDEB Patients

As reported by The Manila Times, Abeona Therapeutics has announced that Cincinnati Children’s Hospital Medical Center has been designated as the seventh Qualified Treatment Center (QTC) authorized to administer ZEVASKYN®…

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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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