The Archive

Briefings

Weekly intelligence on biotech deals, CDE filings, and BIOSECURE compliance.

16 issues published · Every Thursday since December 2025

Showing 2 briefings tagged “FDA” · Clear filter

January 30, 20263 min read

Biotech Intelligence #5: FDA Accepts Ivonescimab BLA — PDUFA Date Set for November 14, 2026

The FDA has accepted Summit Therapeutics' BLA for ivonescimab with a PDUFA target action date of November 14, 2026. We analyze what this means for the bispecific competitive landscape and track the latest BIOSECURE SEC disclosure wave.

FDABispecificOncologyBIOSECURECDE Filing

January 16, 20263 min read

Biotech Intelligence #3: Ivonescimab BLA Filed — The First China-Originated Bispecific Headed for FDA Approval

Summit Therapeutics submitted a BLA to the FDA for Akeso's ivonescimab (PD-1/VEGF bispecific) in EGFR-mutant NSCLC. If approved, it would be the first China-originated bispecific antibody to reach the US market — and a validation of the entire China-to-West licensing model.

BispecificOncologyCDE FilingFDALicensing