PipelineReview.com8h
Bio-Thera Solutions Announces Regulatory Filing Acceptance for BAT2506, a Proposed Biosimilar to Simponi®, in the European Union
GUANGZHOU, China I 7, 2025 I Bio-Thera Solutions Inc. (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative ...
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Maze Therapeutics Doses First Patient in Phase 2 HORIZON Clinical Trial Evaluating MZE829 as a Potential Treatment for APOL1 Kidney Disease
SOUTH SAN FRANCISCO, CA, USA I 07, 2025 I Maze Therapeutics, Inc. (Nasdaq: MAZE), a clinical-stage biopharmaceutical company harnessing the power of ...
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Notice Concerning the Transfer of Mitsubishi Tanabe Pharma Corporation and its Subsidiaries
I Mitsubishi Chemical Group Corporation (MCG) hereby announces that it has resolved, at a meeting of the Board of Directors held today, to ...
PipelineReview.com15h
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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Wave Life Sciences Announces Initiation of Phase 1 INLIGHT Clinical Trial of WVE-007 in Obesity
WVE-007 is a novel, long-acting GalNAc-siRNA targeting INHBE mRNA – a genetically validated target that provides a new approach for healthy, sustainable ...
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Equillium Announces Positive Data from Phase 2 Study Evaluating Itolizumab in Patients with Moderate to Severe Ulcerative Colitis
Itolizumab demonstrated clinical efficacy after 12 weeks of treatment, achieving a clinical remission rate of 23.3% compared to 20.0% for adalimumab and 10.0% ...
PipelineReview.com2d
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 ...