PHAR News and Press, Pharming Group N.V. From 02/16/23

Pharming provides update on EMA regulatory review of leniolisib for APDS in Europe Canada NewsWire EMA Marketing Authorisation Application for leniolisib changed to standard review timetable LEIDEN, Netherlands , Feb. 16, 2023 /CNW/ -- Pharming Group N.V. ("P...

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 Canada NewsWire V. Koneti Rao , MD, shared new evidence of long-term safety and hema...

Pharming ( NASDAQ: PHAR ) said data from a phase 3 trial of its drug to treat adult and adolescent patients with activated phosphoinositide 3-kinase delta syndrome (APDS) were published in the medical journal Blood . The data from this study were previously announced in Februa...

Pharming announces publication of data from Phase 3 Study of leniolisib in patients with APDS in ASH's Blood Canada NewsWire Leniolisib was well tolerated and significant improvement over placebo was notable in the co-primary endpoints, reflecting a favorable impact on patient...

Pharming Group announces presentation of new leniolisib data at 2022 ASH Annual Meeting PR Newswire Presentation to highlight data from the ongoing long-term open-label extension study of leniolisib, a PI3Kδ inhibitor under investigation for APDS, a rare primary i...

Pharming Group N.V. (PHGUF) Q3 2022 Earnings Conference Call October 27, 2022 7:30 AM ET Company Participants Sijmen de Vries - Chief Executive Officer Anurag Relan - Chief Medical Officer Jeroen Wakkerman - Chief Financial Officer Conference Call Participa...

Pharming Announces European Medicines Agency (EMA) Validates its Marketing Authorisation Application under Accelerated Assessment for leniolisib Canada NewsWire Marketing authorisation in the European Economic Area anticipated in H1 2023 LEIDEN, Netherlan...

Pharming submits a Marketing Authorisation Application to the European Medicines Agency for Leniolisib Canada NewsWire Application is based on randomized, controlled and long-term extension data for leniolisib as a treatment for APDS, a rare primary i...

The U.S. Food and Drug Administration ((FDA) granted priority review to Pharming ( NASDAQ: PHAR ) application seeking approval of oral drug leniolisib to treat the rare primary immunodeficiency activated phosphoinositide 3-kinase delta syndrome (APDS) in patients 12 years ...

Pharming Announces US FDA Acceptance for Priority Review of its New Drug Application for Leniolisib Canada NewsWire 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 len...