Pharming Announces US FDA Acceptance for Priority Review of its New Drug Application for Leniolisib

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 immunodeficiency Pharming Group N.V. (“Pharming” or “the Company”) (Euronext Amsterdam: PHARM) (NASDAQ: PHAR) announces that the US Food and Drug Administration (FDA) […]

thaipr.net

30 ก.ย. 65

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 Pharming Group N.V. (“Pharming” or “the Company”) (EURONEXT Amsterdam: PHARM) (Nasdaq: PHAR) announces that the European Medicines Agency’s (EMA) Committee for Medicinal Products for […]

thaipr.net

2 ส.ค. 65