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FDA starts July approvals strong, eight PDUFAs remain
At least eight products await FDA decisions in July
July 10, 2025 8:39 PM UTC
After approving three new products in early July, FDA has at least eight more decisions coming up this month.
On July 2, the agency granted two accelerated approvals. Dizal (Jiangsu) Pharmaceutical Co. Ltd. (Shanghai:688192) marked its first U.S. approval with Zegfrovy sunvozertinib to treat non-small cell lung cancer with EGFR exon 20 insertion mutations. Lynozyfic linvoseltamab from Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) received accelerated approval to treat multiple myeloma, ahead of its July 10 PDUFA date...