Phase 1 Clinical Study Initiated to Evaluate EVO756 for Chronic Spontaneous Urticaria
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Phase 1 Clinical Study Initiated to Evaluate EVO756 for Chronic Spontaneous Urticaria

Chronic spontaneous urticaria (hives) - an itch that can't be scratched. Well, from a literal perspective, you can scratch. But the chronic nature of chronic spontaneous urticaria means that your hives will…

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ICYMI: FDA Clears CNTY-101 IND Application for Lupus
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ICYMI: FDA Clears CNTY-101 IND Application for Lupus

A drug cannot be transported or distributed across state lines until its marketing application has been approved/cleared, so getting this clearance is crucial for many drug developers and physicians who…

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A Phase 1/2 Trial on AIV001 for Basal Cell Carcinoma is Now Complete
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A Phase 1/2 Trial on AIV001 for Basal Cell Carcinoma is Now Complete

  AIV001 (axitinib): a potential, non-surgical therapeutic option for people with basal cell carcinoma (BCC). AiViva Biopharma describes AIV001 as: a novel formulation of a multi-kinase inhibitor combined with AiViva’s…

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ICYMI: TAR-200 for High-Risk Non-Muscle-Invasive Bladder Cancer Granted Breakthrough Therapy Designation
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ICYMI: TAR-200 for High-Risk Non-Muscle-Invasive Bladder Cancer Granted Breakthrough Therapy Designation

In the United States, Breakthrough Therapy designation is granted by the U.S. Food and Drug Administration (FDA) to expedite drug development and review. This designation is granted to therapies that…

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STUDY: Keytruda + mRNA-4157 (V940) Vaccine Reduced Risk of Severe Melanoma Recurrence
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STUDY: Keytruda + mRNA-4157 (V940) Vaccine Reduced Risk of Severe Melanoma Recurrence

In an investor news release from December 2023, Moderna and Merck shared follow-up data from the Phase 2b KEYNOTE-492/mRNA-4157-P201 clinical trial. During the trial, researchers explored the impact of Keytruda…

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ICYMI: LP-284 Earns Orphan Drug Designation for High-Grade B-Cell Lymphoma with MYC/BCL2 Rearrangements
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ICYMI: LP-284 Earns Orphan Drug Designation for High-Grade B-Cell Lymphoma with MYC/BCL2 Rearrangements

  Have you ever heard of Orphan Drug designation? This designation, granted by the U.S. Food and Drug Administration (FDA), is given to drugs or biologics that are designed to treat,…

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Deucrictibant Reduces Monthly HAE Attacks by 84.5% in Phase 2 Study
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Deucrictibant Reduces Monthly HAE Attacks by 84.5% in Phase 2 Study

  Last year, the FDA placed a clinical hold on an Investigational New Drug (IND) application for deucrictibant for the on-demand and prophylactic treatment of individuals living with hereditary angioedema…

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Phase 3 Program on Cobitolimod for UC Discontinued After Inability to Meet Primary Endpoint
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Phase 3 Program on Cobitolimod for UC Discontinued After Inability to Meet Primary Endpoint

  The risk of developing an inflammatory bowel disease (IBD) such as Crohn's disease or ulcerative colitis (UC) has been slowly but steadily increasing over time, with an estimated 0.8%…

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Updated Phase 1/2 Data Highlights Vepdegestrant Benefits for ER+ HER2- Breast Cancer
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Updated Phase 1/2 Data Highlights Vepdegestrant Benefits for ER+ HER2- Breast Cancer

  A Phase 1/2 clinical trial sought to evaluate the potential of vepdegestrant as a therapeutic option for heavily pretreated individuals with estrogen receptor-positive (ER+) and HER2 negative (HER2-) advanced…

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Alofisel for Complex Perianal Fistulas (CPF) Falls Short in Phase 3 Trial
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Alofisel for Complex Perianal Fistulas (CPF) Falls Short in Phase 3 Trial

  When drugs enter into clinical studies, both patients and drug developers alike hope for success. These therapies could transform the treatment sphere, especially in disease states with limited or…

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VERVE-101 Shows Promise in Treating HeFH, Phase 1b Study Results Show

Heterozygous familial hypercholesterolemia (HeFH) can be difficult to control on available standard-of-care cholesterol-lowering medications. Therapeutic interventions are needed to reduce high LDL cholesterol levels and improve health and quality-of-life for…

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