News about "Pharming Group "

Pharming Launches Joenja in Japan for APDS Patients Aged 4 and Older

Pharming Launches Joenja in Japan for APDS Patients Aged 4 and Older

Pharming has launched Joenja in Japan for APDS patients aged 4 years and older, making Japan the first market to offer the treatment commercially to children aged 4–11.

Pharming Group | 14/08/2026 | By News Bureau

Pharming Launches Joenja in Japan for APDS Patients Aged 4 Years and Older

Pharming Launches Joenja in Japan for APDS Patients Aged 4 Years and Older

Pharming has launched Joenja (leniolisib) in Japan for adults and children aged 4 years and older with APDS, marking its first commercial availability for children aged 4 to 11 years.

Pharming Group | 13/08/2026 | By News Bureau

Pharming Secures EU Approval for Joenja as First Targeted Treatment for Rare Immune Disorder APDS

Pharming Secures EU Approval for Joenja as First Targeted Treatment for Rare Immune Disorder APDS

Pharming Group has received European Commission approval for Joenja, expanding treatment access for patients with activated PI3K delta syndrome and strengthening therapeutic options for rare immune disorders.

Pharming Group | 26/05/2026 | By News Bureau 104

Pharming Gets Complete Response Letter from US FDA for Joenja

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.

Pharming Group | 02/02/2026 | By News Bureau 219

Pharming Unveils Positive Topline Data in Pediatric Clinical Trial of Leniolisib

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.

Pharming Group | 13/12/2024 | By Aishwarya 375

Pharming Completes Enrollment in Pediatric Clinical Trial of leniolisib

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.

Pharming Group | 09/04/2024 | By Aishwarya 552


 

 

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