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PDUFA

4 stories

Cited Again: Hengrui's 9-Flaw 483 Stalls Liver Drug

Hengrui cleared one FDA citation in six days, only to get hit with a second Form 483, nine observations deep, at a different plant.

FDA Jul 22, 2026

GSK's Jideytro Wins First FDA Lung Cancer Nod

GSK turned a $10.6B buyout into an FDA approval in a week. The real question is whether Jideytro can outrun a rival that's barely moving units.

FDA Apr 14, 2026

FDA Cleared Filspari for FSGS Despite Phase 3 Fail, Opening $2B Market

FDA cleared Filspari for focal segmental glomerulosclerosis on Monday, making Travere Therapeutics' endothelin blocker the first and only approved drug for…

FDA Apr 5, 2026

Lilly's Oral GLP-1 Pill Cleared in 50 Days, Fastest NME Since 2002

Eli Lilly's oral GLP-1 pill orforglipron approved in 50 days under the FDA's CNPV pilot — the fastest new molecular entity approval since 2002.