The multinational Phase III study is evaluating leniolisib tablets in children aged 4 to 11 years with APDS, a rare primary immunodeficiency Pharming Group N.V. ("Pharming" or "the Company") (EURONEXT Amsterdam: PHARM...
EMA Marketing Authorisation Application for leniolisib changed to standard review timetable Pharming Group N.V. ("Pharming" or "the Company") (EURONEXT Amsterdam: PHARM) (Nasdaq: PHAR) announces that the European...
Leniolisib was well tolerated and significant improvement over placebo was notable in the co-primary endpoints, reflecting a favorable impact on patients' immune dysregulation and deficiency...
Marketing authorisation in the European Economic Area anticipated in H1 2023 Pharming Group N.V. ("Pharming" or "the Company") (EURONEXT Amsterdam: PHARM /...
Application is based on randomized, controlled and long-term extension data for leniolisib as a treatment for APDS, a rare primary immunodeficiency This submission follows the grant of accelerated...
The FDA has assigned a PDUFA goal date of March 29, 2023 for the NDA submission based on randomized-controlled and long-term extension data for leniolisib as a treatment for APDS, a rare primary...
Implemented by the Centers for Disease Control and Prevention, the diagnosis code will accurately identify US patients with APDS, supporting care and research efforts Pharming Group N.V. ("Pharming" or "the Company") ...
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...
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...