PipelineReview.com6h
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 ...
PipelineReview.com6h
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.com12h
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 ...
PipelineReview.com12h
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.com12h
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 ...
PipelineReview.com12h
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 ...
PipelineReview.com2d
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 ...
PipelineReview.com2d
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 ...
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) – ...
PipelineReview.com2d
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 ...
PipelineReview.com3d
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 ...
PipelineReview.com4d
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 ...