TOKYO, Japan — Zenyaku Kogyo Co., Ltd. (website in Japanese only) and Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced today that Zenyaku obtained regulatory approval from the Ministry of Health, Labour and Welfare (MHLW), for an additional indication of an anti-CD20 monoclonal antibody Rituxan® intravenous injection 100 mg and 500 mg [generic name: rituximab...
treatment News
Anti-rheumatic drugs used for rheumatoid arthritis might prevent the development of autoimmune thyroid disease, according to a new observational study by researchers from Karolinska Institutet published in the Journal of Internal Medicine. Solna, Sweden – It is well known that patients with rheumatoid arthritis are at increased risk of...
HAYWARD, Calif. – Arcus Biosciences, Inc. (NYSE:RCUS), an oncology-focused biopharmaceutical company working to create best-in-class cancer therapies, announced that, at the first interim analysis of the three-arm randomized Phase 2 ARC-7 study, both arms with domvanalimab-based combinations showed encouraging clinical activity (measured by overall response rate; ORR) when given as...
Los Angeles, California. Treatment with datopotamab deruxtecan (Dato-DXd), a novel Trop-2 directed antibody-drug conjugate, was found to significantly improve progression-free survival in patients with metastatic non-small cell lung cancer, an improvement that was primarily driven by patients with non-squamous tumors. These results from the TROPION-Lung01 Phase III trial, which compared the standard...
CAMBRIDGE, Mass. — Anumana, Inc., a leader in cardiovascular AI, today announced U.S. Food and Drug Administration (FDA) clearance of its ECG-AI™ algorithm for cardiac amyloidosis (CA) – the first and only cleared for this indication using standard 12-lead electrocardiograms (ECGs). The AI-enabled software-as-a-medical-device (SaMD), previously granted FDA Breakthrough Device Designation and...
Robust proteinuria reduction and stable kidney function were maintained across a broad population of patients No new safety signals were observed New data presented at late-breaking session at the European Renal Association Congress Marketing applications for EMPAVELI are under review with the FDA and EMA WALTHAM, Mass. and STOCKHOLM, Sweden...
WALTHAM, Mass. — Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review designation of the supplemental New Drug Application (sNDA) for EMPAVELI® (pegcetacoplan) for C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN), which are severe and rare...
SAN CARLOS, Calif. — Aperture Therapeutics, a biotechnology company pioneering next-generation precision medicines for neurodegenerative diseases, today announced the advancement of its matrix metalloproteinase-9 (MMP9) antisense oligonucleotide (ASO) program, APRTX-003, for the treatment of Amyotrophic Lateral Sclerosis (ALS). The program targets chronic neuroinflammation and neurodegeneration, two core pathological drivers of motor neuron degeneration...
CAMBRIDGE, Mass. – Apic Bio, Inc., an innovative gene therapy company developing novel treatment options for patients with rare genetic diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for APB-102, the Company’s lead gene therapy candidate designed to treat...
FOSTER CITY, Calif. — Apollomics Inc., a clinical-stage biopharmaceutical company developing medicines to address difficult-to-treat cancers, today announced the completion of enrollment in its Phase 3 bridging study evaluating uproleselan (APL-106), an investigational, first-in-class E-selectin antagonist, added to a standard chemotherapy regimen for the treatment of adults with relapsed or...