Belimumab Dose Spacing May Be an Option for Selected Patients With SLE in Sustained Remission

As reported on MedScape, gradually extending the interval between belimumab doses may allow carefully selected patients with systemic lupus erythematosus (SLE) in long-term remission to reduce treatment exposure (and in…

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FDA Grants Breakthrough Therapy Designation to Pemafibrate for Primary Biliary Cholangitis

As reported on PR Newswire, the US Food and Drug Administration has granted Breakthrough Therapy designation to Kowa’s investigational therapy K-808 (pemafibrate) for primary biliary cholangitis (PBC), the company announced.…

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Enfortumab Vedotin/Pembrolizumab Regimen Outperforms Neoadjuvant Chemotherapy in Resectable MIBC

As reported on The ASCO Post, perioperative treatment with enfortumab vedotin-ejfv plus pembrolizumab resulted in superior event-free survival, overall survival, and pathologic response rates compared with neoadjuvant cisplatin/gemcitabine in cisplatin-eligible…

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Axsome Launches Phase 3 CLARITY Study of Solriamfetol for Depression Patients Experiencing Daytime Sleepiness

As reported by The Manila Times, Axsome Therapeutics has announced the initiation of its Phase 3 CLARITY clinical trial evaluating solriamfetol as a potential treatment for adults with major depressive…

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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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