FDA Grants Orphan Drug Designation for Bexmarilimab in MDS
“Receiving FDA’s orphan drug designation for bexmarilimab for the treatment of myelodysplastic syndrome marks a significant milestone for Faron Pharmaceuticals as we continue to develop bexmarilimab for MDS and other cancers. This FDA ODD along with the previously granted FDA fast track designation highlights our continued progress and reinforces our belief in the potential of bexmarilimab to address this significant unmet need for treatment of MDS. These designations allow us to receive important regulatory guidance for the development of bexmarilimab and potential additional market exclusivity upon approval” says Dr. Bono, the CMO of Faron.
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