FDA
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.
FDA actions, warning letters, CRLs, approvals, and regulatory enforcement.
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.
Trump's 100% tariff on branded pharma imports creates a hard deadline: cut MFN pricing deals and reshore, or face full tariffs by 2030.
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