Posted by Michael Wonder on 14 Feb 2023
Soligenix receives refusal to file letter from US FDA for HyBryte new drug application in the treatment of cutaneous T-Cell lymphoma
14 February 2023 - Soligenix intends to seek guidance from the FDA on how to further advance HyBryte towards potential approval.
Soligenix announced today that the US FDA has provided the Company with a refusal to file letter for its HyBryte (synthetic hypericin) new drug application in the treatment of early stage cutaneous T-cell lymphoma, a rare cancer and area of unmet medical need affecting over 25,000 patients in the US.
