PipelineReview.com19h
Rybelsus® (oral semaglutide 14 mg) demonstrates superior reduction in cardiovascular events in the SOUL trial at ACC 2025
BAGSVAERD, Denmark I March 29, 2025 I Novo Nordisk today presented the full results from the SOUL cardiovascular outcomes trial, demonstrating that Rybelsus® ...
PipelineReview.com1d
Qfitlia approved as the first therapy in the US to treat hemophilia A or B with or without inhibitors
PARIS, France I March 28, 2025 I The US Food and Drug Administration (FDA) has approved Qfitlia (fitusiran), the first antithrombin-lowering (AT) therapy for ...
PipelineReview.com2d
Palatin Announces Positive Topline Results from Phase 2 Ulcerative Colitis (UC) Study of Oral Melanocortin-1 Receptor Agonist PL8177
CRANBURY, NJ, USA I March 28, 2025 I Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company developing first-in-class medicines based on ...
PipelineReview.com2d
Spyre Therapeutics Announces First Participant Dosed in Phase 1 Trial of SPY003, its Novel Half-life Extended IL-23 Antibody
Preclinical data demonstrates that SPY003 is highly potent and has potential forquarterly or biannual dosing, suggesting opportunity for improved efficacy ...
PipelineReview.com2d
European Medicines Agency (EMA) Validates Henlius and Organon Filing for Perjeta® (pertuzumab) Biosimilar Candidate HLX11
SHANGHAI, China & JERSEY CITY, NJ, USA I March 28, 2025 I Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) today announced that the ...
PipelineReview.com2d
Richter Announces Submission to European Medicines Agency for Biosimilar Tocilizumab in Multiple Indications
I Gedeon Richter Plc. announces today that the European Medicines Agency has accepted Richter’s marketing authorization application (MAA) for ...
PipelineReview.com4d
AnHorn Medicines Announces First Subject Dosed in AH-001 Phase I Clinical Trial in the United States
TAIPEI, Taiwan I March 26, 2025 I AnHorn Medicines, a pioneering AI-driven new drug discovery company, is pleased to announce that, AH-001, a first-in-class ...
PipelineReview.com3d
Alys Pharmaceuticals Announces Dosing of First Patient in Phase IIa Trial of ALY-101 for Alopecia Areata
BOSTON, MA, USA and LAUSANNE, Switzerland I March 27, 2025 I Alys Pharmaceuticals, Inc. ("Alys"), an immune-dermatology focused company, today announces that ...
PipelineReview.com3d
Equillium Announces Results of the Phase 3 EQUATOR Study of Itolizumab in First-Line Treatment of Patients with Acute Graft-Versus-Host Disease
Per the study protocol, patients received itolizumab within 3-days of the first administration of high-dose corticosteroids with a treatment period from Days 1-99, and a follow-up period from Days 100 ...
PipelineReview.com3d
Actinium Pharmaceuticals Announces ATNM-400 a Novel Non-PSMA Targeting First in Class Prostate Cancer Radiotherapy Leveraging Actinium-225
Title: ATNM-400 is a novel Actinium-225 antibody radioconjugate with strong efficacy in preclinical models of prostate cancer ...
PipelineReview.com3d
Fresenius Receives FDA Approval for their Denosumab Biosimilars and Secures Global Settlement Agreement
LAKE ZURICH, IL, USA I March 27, 2025 I Fresenius announced that the Biologics License Application (BLA) for the denosumab biosimilars Conexxence® ...
PipelineReview.com4d
Vaximm AG, an OSR Company, Announces Results from Phase 2a Trial of VXM01 and Avelumab Combination Therapy in Glioblastoma
Results from Phase 2a Trial demonstrate a good safety and tolerability profile of VXM01 and Avelumab Combination Therapy in Glioblastoma, supporting further ...