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Once-weekly Mim8 is well-tolerated and efficacious in children living with haemophilia A with and without inhibitors
Phase 3 FRONTIER3 interim analysis data presented at EAHAD 2025 showed that 74.3% of children on once-weekly Mim8 prophylaxis experienced zero treated ...
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Denali Therapeutics Announces Primary Analysis and Long-Term Follow-Up of Phase 1/2 Study in Hunter Syndrome (MPS II) with Tividenofusp Alfa
SOUTH SAN FRANCISCO, CA, USA I 06, 2025 I Denali Therapeutics Inc. (NASDAQ: DNLI), today announced the primary analysis of the Phase 1/2 study in 47 ...
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FDA Approves Genentech’s Susvimo as the First and Only Continuous Delivery Treatment for the Leading Cause of Diabetes-Related Blindness
Susvimo is the first and only continuous delivery treatment that offers an alternative to regular eye injections to treat diabetic macular edema (DME) – ...
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Aro Biotherapeutics Announces U.S. FDA Clearance of IND Application for ABX1100 for Potential Treatment of Late-Onset Pompe Disease (LOPD)
Announcement coincides with WORLDSymposium™ presentation highlighting knockdown of GYS1 mRNA and protein in muscle, as well as favorable safety and ...
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Serplulimab Approved in the EU for First-Line Treatment of Extensive-Stage Small Cell Lung Cancer (ES-SCLC)
SHANGHAI, China I 5, 2025 I Shanghai Henlius Biotech, Inc. (2696.HK) announced that its anti-PD-1 mAb, HANSIZHUANG (serplulimab, marketed as ...
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Harbour BioMed Receives NMPA IND Clearance for HBM9378/SKB378 in the Treatment of Chronic Obstructive Pulmonary Disease
CAMBRIDGE, MA, USA; ROTTERDAM, The Netherlands and SHANGHAI, China I 4, 2025 I Harbour BioMed (HKEX: 02142, the "Company"), a global ...
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Auron Therapeutics Announces FDA Clearance to Initiate Clinical Development of AUTX-703 and Completion of Series B Financing
Preparing to Initiate Clinical Development in Patients with Hematologic Malignancies in the First Quarter of 2025 ...
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COUR Pharmaceuticals Secures FDA Clearance of IND Application for CNP-103 in Type 1 Diabetes
CHICAGO, IL, USA I 04, 2025 I COUR Pharmaceuticals, a clinical-stage biotechnology company developing first-in-class, disease-modifying therapies ...
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Alys Pharmaceuticals receives IND clearance for Phase 2a trial of first genetic medicine program in dermatology
BOSTON, MA, USA and LAUSANNE, Switzerland I 4, 2025 I Alys Pharmaceuticals, Inc. ("Alys"), an immune-dermatology focused company, today announces ...
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Pfizer’s BRAFTOVI® Combination Regimen Significantly Improved Progression-Free Survival and Overall Survival in Phase 3 BREAKWATER Trial
NEW YORK, NY, USA I 03, 2025 I Pfizer Inc. (NYSE: PFE) today announced positive topline results from the progression-free survival (PFS) analysis of ...
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HCW Biologics Granted FDA Clearance to Evaluate One of the Company’s Lead Product Candidates in a First-In-Human Phase 1 Clinical Trial
This study will evaluate HCW9302 in patients with moderate to severe alopecia areata. MIRAMAR, FL, USA I 03, 2025 I HCW Biologics Inc. (“HCWB” or the “Company”) ( ...
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Inhalon Biopharma Announces First-of-its-Kind Inhaled Antibody Treatment for RSV to Enter Human Clinical Trials
New at-home RSV treatment represents a potential breakthrough in addressing the burden of respiratory diseases, especially in vulnerable pediatric and elderly ...