BURLINGTON, Mass. — PharmaEssentia USA Corporation, a subsidiary of PharmaEssentia Corporation (TWSE: 6446), a global biopharmaceutical innovator based in Taiwan leveraging deep expertise and proven scientific principles to deliver new biologics in hematology and oncology, today announced that the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines®)...
treatment News
PERTH, Australia — PharmAust Limited (ASX: PAA & PAAOA), a clinical-stage biotechnology company, is pleased to announce that it has met its primary safety and tolerability endpoints with monepantel (MPL) and, importantly, demonstrated a positive signal of potential efficacy. Rates of disease progression in patients with Motor Neurone Disease (MND)...
Leiden, The Netherlands – Pharming Group N.V. (“Pharming” or “the Company”) (Euronext Amsterdam: PHARM/Nasdaq: PHAR) announces the successful completion of patient enrolment in the pivotal Phase II/III triple-blind, randomized, placebo-controlled study of leniolisib for the treatment of activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS). Leniolisib is a small molecule PI3Kδ inhibitor...
Leiden, the Netherlands – Pharming (Euronext Amsterdam: PHARM/Nasdaq: PHAR), a global biotechnology company focused on rare immune and genetic diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) seeking approval for lower doses of Joenja® (leniolisib), an oral, selective phosphoinositide 3-kinase delta...
Leiden, The Netherlands – Pharming Group N.V. (EURONEXT Amsterdam: PHARM)/(Nasdaq: PHAR) announces that the first patient has been dosed in its Phase III pediatric clinical trial evaluating a new pediatric formulation of the investigational drug leniolisib, an oral, selective phosphoinositide 3-kinase delta (PI3Kδ) inhibitor, in children ages one to six...
Leiden, The Netherlands – Pharming Group N.V. announced today the expansion of its rare disease pipeline with plans to develop leniolisib for additional primary immunodeficiencies (PIDs) beyond activated phosphoinositide 3-kinase delta syndrome (APDS). Pharming has engaged with the US Food and Drug Administration (FDA) and has received feedback on its plans...
Leiden, the Netherlands, October 1, 2025: Pharming Group N.V. (“Pharming” or “the Company”) (Euronext: PHARM; Nasdaq: PHAR) today announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) seeking approval for leniolisib, an oral, selective phosphoinositide 3-kinase delta (PI3Kδ) inhibitor, as a treatment...
Leiden, the Netherlands – Pharming Group N.V. (“Pharming” or “the Company”) (EURONEXT Amsterdam: PHARM/Nasdaq: PHAR) announces that the first patient has been dosed in a Phase II, proof of concept, clinical trial evaluating leniolisib in common variableimmunodeficiency (CVID) patients with immune dysregulation. The Phase II clinical trial is a single...
LEIDEN, the Netherlands – Pharming Group N.V. (“Pharming” or “the Company”) (Euronext Amsterdam: PHARM/Nasdaq: PHAR) today announced presentations at the 2026 Annual Meeting of the Clinical Immunology Society (CIS), taking place May 6-9 in New Orleans, LA. Across multiple presentations, the Company and its collaborators will share interim outcomes of...
LEIDEN, the Netherlands – Pharming Group N.V. (“Pharming” or “the Company”) (EURONEXT Amsterdam: PHARM/Nasdaq: PHAR) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorization for Joenja® (leniolisib) for the treatment of activated phosphoinositide 3-kinase delta syndrome (APDS),...