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Pharming Group provides updates on EMA regulatory review of leniolisib MAA and plans to file for UK regulatory approval

Corporate updates

Pharming Group N.V. announces that it has received a Day 180 Second List of Outstanding Issues (LoOI) from the European Medicines Agency’s (EMA) Committee for Human Medicinal Products (CHMP) regarding its Marketing Authorisation Application (MAA) for leniolisib for adult and pediatric patients 12 years of age and older with APDS, a rare primary immunodeficiency. Based on the timetable included in the CHMP Day 180 Second LoOI, and considering the CHMP’s decision to reschedule the Ad-Hoc Expert Group (AEG) meeting to the end of November, Pharming now expects the CHMP to issue its opinion on the leniolisib MAA in the first quarter of 2024.

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Pharming Group announces presentations at International Primary Immunodeficiencies Congress and the American College of Allergy, Asthma & Immunology Annual Scientific Meeting

Conference attendance

Pharming Group N.V. announces 14 poster presentations by the Company or its collaborators regarding leniolisib and RUCONEST® at the International Primary Immunodeficiencies Congress (IPIC) and the American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting in November.

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