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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.
Complete Response Letter | 02/02/2026 | By News Bureau | 171
Tiziana Submits Annual Safety Report for Intranasal Foralumab to FDA
Tiziana has submitted its annual safety report for intranasal foralumab to the US FDA, reporting an excellent safety profile based on 37.4 cumulative patient-years of exposure and highlighting the continued need for safer therapies following the FDA’s denial of Sanofi’s tolebrutinib for non-relapsing secondary progressive multiple sclerosis.
Complete Response Letter | 30/12/2025 | By News Bureau | 140
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