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News about "Leniolisib"
Pharming Gets Complete Response Letter from US FDA for Joenja
The US FDA issued a Complete Response Letter to Pharming Group for the supplemental NDA for Joenja, citing the need for additional information to support its use in children aged four to 11 years with activated phosphoinositide 3-kinase delta syndrome, a rare primary immunodeficiency.
Leniolisib | 02/02/2026 | By News Bureau | 155
Pharming Unveils Positive Topline Data in Pediatric Clinical Trial of Leniolisib
Pharming plans to include data from this 4-11-year-old trial in regulatory filings worldwide for the approval of leniolisib for pediatric patients with APDS, beginning in 2025.
Leniolisib | 13/12/2024 | By Aishwarya | 317
Pharming Completes Enrollment in Pediatric Clinical Trial of leniolisib
Pharming Group has recently completed patient enrollment in its Phase III clinical trial (NCT05438407) evaluating the investigational drug leniolisib.
Leniolisib | 09/04/2024 | By Aishwarya | 463
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