News about "The US Food and Drug Administration"

Bayer Secures Breakthrough Status for Sevabertinib in HER2 NSCLC

Bayer Secures Breakthrough Status for Sevabertinib in HER2 NSCLC

US FDA and China’s CDE granted the designation for sevabertinib as a potential first-line therapy in advanced HER2-mutant non-small cell lung cancer.

The US Food And Drug Administration | 07/01/2026 | By News Bureau 117

US FDA Grants Six More Priority Review Vouchers to Accelerate Drug Approvals

US FDA Grants Six More Priority Review Vouchers to Accelerate Drug Approvals

The US Food and Drug Administration (FDA) has awarded six additional companies under its “Commissioner’s National Priority Voucher” programme, bringing the total number of recipients to fifteen.

The US Food And Drug Administration | 07/11/2025 | By Darshana 153


 

 

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