Lilly’s Retatrutide Achieves Strong Weight Loss and Glycemic Benefits in Two Phase 3 Obesity Studies

As reported on Drugs, Eli Lilly has reported positive topline findings from two additional Phase 3 trials of retatrutide, its investigational triple hormone receptor agonist designed to target GIP, GLP-1,…

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EMA Backs Enhertu Plus Pertuzumab as Potential New First-Line Standard for HER2-Positive Metastatic Breast Cancer

As reported on PharmaBiz, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive recommendation supporting approval of AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate…

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Novel HIV Vaccine Generates Strong Broadly Neutralizing Antibody Responses in Preclinical Study

Researchers from La Jolla Institute for Immunology (LJI), Scripps Research, and IAVI have reported a major advance in HIV vaccine development, demonstrating an experimental vaccine strategy that produced unusually strong…

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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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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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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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