The U.S. FDA approved 17 drugs in July, down from 23 in June, bringing the year-to-date total to 125. Through July, 2025 remains the third-highest count in BioWorld’s records, trailing 135 approvals in 2024 and 126 in 2020.
The U.S. FDA approved 17 drugs in July, down from 23 in June, bringing the year-to-date total to 125. Through July, 2025 remains the third-highest count in BioWorld’s records, trailing 135 approvals in 2024 and 126 in 2020.
Four days ahead of its July 7 PDUFA date, the U.S. FDA granted accelerated approval to Dizal (Jiangsu) Pharmaceutical Co. Ltd.’s sunvozertinib (DZD-9008), branded as Zegfrovy, for treating adults with locally advanced or metastatic non-small-cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations following platinum-based chemotherapy.
Four days ahead of its July 7 PDUFA date, the U.S. FDA granted accelerated approval to Dizal (Jiangsu) Pharmaceutical Co. Ltd.’s sunvozertinib (DZD-9008), branded as Zegfrovy, for treating adults with locally advanced or metastatic non-small-cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations following platinum-based chemotherapy.
