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News about "complete response letter "
US FDA Issues Complete Response Letter for Ascelia Pharma's Orviglance NDA
Ascelia Pharma has received a Complete Response Letter from the US FDA for its New Drug Application for Orviglance, prompting the company to seek further regulatory discussions while reaffirming its commitment to advancing the rare oncology therapy.
Complete Response Letter | 06/07/2026 | By News Bureau | 314
Galderma has received a Complete Response Letter from the US FDA for its RelabotulinumtoxinA Biologics License Application, with observations limited to manufacturing processes and analytical methods.
Complete Response Letter | 02/07/2026 | By News Bureau | 142
Sobi Receives FDA Complete Response Letter for Experimental Gout Therapy NASP
Sobi has received a Complete Response Letter from the US FDA for its investigational gout therapy NASP, with the regulator requesting additional manufacturing data and facility-related information before considering approval. The company plans to work with the FDA and its manufacturing partners toward resubmitting the application.
Complete Response Letter | 29/06/2026 | By News Bureau
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 | 212
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 | 215
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