Pharming announces US FDA approval of Joenja® (leniolisib) as the first and only treatment indicated for APDS
APDS (activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome) is a rare and progressive primary immunodeficiency Joenja® is a targeted treatment of APDS for adult and pediatric patients 12 years of age and older Joenja® is expected to launch in the US in early April Pharming will host a con...
Pharming announces first patient enrolled in pediatric clinical trial of leniolisib
The multinational Phase III study is evaluating leniolisib tablets in children aged 4 to 11 years with APDS, a rare primary immunodeficiency LEIDEN, Netherlands, Feb. 21, 2023 /PRNewswire/ -- Pharming Group N.V. ("Pharming" or "the Company") (EURONEXT Amsterdam: PHARM)/(Nasdaq: PHAR) announces t...
Pharming provides update on EMA regulatory review of leniolisib for APDS in Europe
EMA Marketing Authorisation Application for leniolisib changed to standard review timetable LEIDEN, Netherlands, Feb. 16, 2023 /PRNewswire/ -- Pharming Group N.V. ("Pharming" or "the Company") (EURONEXT Amsterdam: PHARM) (Nasdaq: PHAR) announces that the European Medicines Agency's (EMA) Committ...
Pharming announces positive interim analysis data from open-label extension study of leniolisib in presentation at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition
V. Koneti Rao, MD, shared new evidence of long-term safety and hematologic response in patients who received leniolisib to treat APDS, a rare primary immunodeficiency Interim analysis demonstrated leniolisib to be well tolerated and indicated the durability of the efficacy results seen in the Ph...
Pharming Announces European Medicines Agency (EMA) Validates its Marketing Authorisation Application under Accelerated Assessment for leniolisib
Marketing authorisation in the European Economic Area anticipated in H1 2023 LEIDEN, Netherlands, Oct. 28, 2022 /PRNewswire/ -- Pharming Group N.V. ("Pharming" or "the Company") (EURONEXT Amsterdam: PHARM / Nasdaq: PHAR) announces today that its Marketing Authorisation Application (MAA) for leni...
Pharming Announces New ICD-10-CM Code for APDS, a Rare Primary Immunodeficiency
Implemented by the Centers for Disease Control and Prevention, the diagnosis code will accurately identify US patients with APDS, supporting care and research efforts LEIDEN, Netherlands, Aug. 2, 2022 /PRNewswire/ -- Pharming Group N.V. ("Pharming" or "the Company") (EURONEXT Amsterdam: PHARM/Na...
Pharming Group Receives Accelerated Assessment in Europe for leniolisib for the Treatment of Rare Immunodeficiency, APDS
EMA accelerated assessment allows a shorter review period for leniolisib from a standard 210 days to 150 days Pharming is on track to submit its Marketing Authorisation Application for leniolisib in H2 2022 LEIDEN, the Netherlands, Aug. 1, 2022 /PRNewswire/ -- Pharming Group N.V. ("Pharming" or...
Pharming Announces Positive Data from Phase II/III Leniolisib Trial Presented at Clinical Immunology Society 2022 Annual Meeting
LEIDEN, Netherlands, April 1, 2022 /PRNewswire/ -- Pharming Group N.V. ("Pharming" or "the Company") (EURONEXT Amsterdam: PHARM/Nasdaq: PHAR) announces new data from the pivotal Phase II/III trial of leniolisib for the treatment of activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS)...
