Lates News

date
23/06/2025
The U.S. Food and Drug Administration (FDA) has designated BioNTech's drug as an orphan drug for small cell lung cancer. On June 22, the FDA granted orphan drug status to the therapy, with its generic name being A. The drug is a recombinant bispecific antibody composed of the light and heavy chains of the anti-VEGF-A antibody bevacizumab, fused to the heavy chain C-terminus of the anti-PD-L1 single-domain antibody through a stable linker (G4S)2G. If approved by the FDA for use in rare diseases, orphan drugs can enjoy a 7-year market exclusivity period.