ThaiPR.NET https://www.thaipr.net/location/leiden-the-netherlands Press Release Distribution Center of Thailand Thu, 30 Apr 2026 18:05:11 +0700 hourly 1 https://wordpress.org/?v=6.1.1 <![CDATA[Pharming Announces US FDA Acceptance for Priority Review of its New Drug Application for Leniolisib]]> https://www.thaipr.net/en/health_en/3246625 Fri, 30 Sep 2022 08:05:21 +0700 health_en https://www.thaipr.net/en/health_en/3246625 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) […]

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]]> <![CDATA[Pharming Group Receives Accelerated Assessment in Europe for leniolisib for the Treatment of Rare Immunodeficiency, APDS]]> https://www.thaipr.net/en/health_en/3218903 Tue, 02 Aug 2022 08:30:16 +0700 health_en https://www.thaipr.net/en/health_en/3218903 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 […]

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