KalVista Reports FDA Delay on Sebetralstat NDA for Hereditary Angioedema Due to Resource Constraints

KalVista Reports FDA Delay on Sebetralstat NDA for Hereditary Angioedema Due to Resource Constraints

KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced that the U.S. Food and Drug Administration (FDA) has notified the Company that it will not meet the PDUFA goal date for the New Drug Application (NDA) for sebetralstat, the Company’s investigational oral…

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Valar Labs’ CHAI Biomarkers Validated in New Study in European Urology for Predicting Outcomes of High Grade Ta Bladder Cancer

Valar Labs’ CHAI Biomarkers Validated in New Study in European Urology for Predicting Outcomes of High Grade Ta Bladder Cancer

Valar Labs, a pioneer in AI-powered diagnostics for oncology, announced the publication of its latest research in European Urology, the highest-impact journal in the field of urology. The peer-reviewed study highlights the performance and clinical impact of Valar Labs’ Vesta platform…

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Cybin Shares Corporate Update and Positive Regulatory Progress for Psychedelic Therapies

Cybin Shares Corporate Update and Positive Regulatory Progress for Psychedelic Therapies

Cybin Inc. (NYSE American:CYBN) (Cboe Canada CA:CYBN) (“Cybin” or the “Company”), a clinical-stage breakthrough neuropsychiatry company committed to revolutionizing mental healthcare by developing new and innovative next-generation treatment options, today provided a corporate update. “It is especially gratifying that at a…

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Astria Therapeutics Shares Promising Early Data from Navenibart Trial in Hereditary Angioedema at EAACI Congress

Astria Therapeutics Shares Promising Early Data from Navenibart Trial in Hereditary Angioedema at EAACI Congress

 a biopharmaceutical company focused on developing life-changing therapies for allergic and immunologic diseases, today announced positive initial results from the target enrollment group in the ongoing ALPHA-SOLAR long-term open-label trial evaluating navenibart (STAR-0215), a monoclonal antibody inhibitor of plasma kallikrein,…

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Zai Lab Unveils Preclinical Data on ZL-1503 for Atopic Dermatitis at EAACI 2025

Zai Lab Unveils Preclinical Data on ZL-1503 for Atopic Dermatitis at EAACI 2025

Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) announced new data from its preclinical study of ZL-1503, the Company’s promising IL-13/IL-31R bispecific antibody, demonstrating its ability to simultaneously suppress the inflammatory and pruritogenic (itch-causing) pathways in atopic dermatitis (AD). The findings,…

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FDA Approves KEYTRUDA® for PD-L1+ Head & Neck Cancer in Neoadjuvant and Adjuvant Settings

FDA Approves KEYTRUDA® for PD-L1+ Head & Neck Cancer in Neoadjuvant and Adjuvant Settings

FDA Approves KEYTRUDA® for PD-L1+ Head & Neck Cancer in Neoadjuvant and Adjuvant Settings Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA® (pembrolizumab), Merck’s…

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Ethris and Thermo Fisher Partner to Expand Access to mRNA Technology Platforms

Ethris and Thermo Fisher Partner to Expand Access to mRNA Technology Platforms

Ethris GmbH, a clinical-stage biotechnology company pioneering next-generation RNA therapeutics and vaccines, today announced a strategic collaboration with Thermo Fisher Scientific, the world leader in serving science, to provide a fully integrated mRNA solution to biopharmaceutical developers. The collaboration brings…

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MaaT Pharma Reports Positive Xervyteg® Data at EHA, Confirming ARES Study Results in GvHD

MaaT Pharma Reports Positive Xervyteg® Data at EHA, Confirming ARES Study Results in GvHD

MaaT Pharma (EURONEXT: MAAT – the “Company”), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival for patients with cancer through immune modulation, today announced that Professor Mohamad Mohty, Professor of Hematology…

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Stanford Health Care and Kivo Health Collaborate to Advance Value Based Care for COPD through Virtual Pulmonary Rehabilitation

Stanford Health Care and Kivo Health Partner to Enhance COPD Care with Virtual Pulmonary Rehab

Stanford Health Care, one of the nation’s leading academic medical centers, tapped Kivo Health as part of a collaboration to advance AI-powered virtual pulmonary rehabilitation and care for patients with Chronic Obstructive Pulmonary Disease (COPD). As part of a broader…

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