A new study showed a reduced risk of hepatocellular carcinoma (HCC) in patients with viral hepatitis who used H1-antihistamines (AHs), compared with those who did not. The results were published in the Journal of Clinical Oncology. The researchers noted that, although H1-AHs are most commonly used to treat allergic reactions...
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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...
Copenhagen, Denmark – 92.8% of patients with systemic lupus erythematosus (SLE) suffer anxiety and depression which significantly affects both their physical and emotional quality of life (QoL), according to the results of a new study presented today at EULAR 2009, the Annual Congress of the European League Against Rheumatism in...
VIENNA, Austria – Since 2017, PharmaEssentia had repeatedly attempted to terminate the agreement with AOP Orphan concerning BESREMi® (Ropeginterferon alfa-2b). After two and a half years of arbitral proceedings, in October 2020, the ICC Arbitral Tribunal issued its award in the matter. The arbitral award states that PharmaEssentia’s multiple attempts...
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...
BETHESDA, Md. and WASHINGTON – The Aplastic Anemia and MDS International Foundation (AAMDSIF) and the National Organization for Rare Disorders (NORD®) today launched the largest-ever study to research Paroxysmal Nocturnal Hemoglobinuria (PNH), a rare bone marrow failure disease. PNH is characterized by the destruction of red blood cells, blood clots and impaired...
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...