CNBC
29 Jun 2026, 18:50 UTC · 3h ago
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The FDA's PreCheck pilot program can accelerate the review of new domestic pharmaceutical manufacturing facilities by up to 14 months. — Significantly reducing time-to-market for manufacturing capabilities directly affects revenue realization and scaling for high-demand drugs.
+0.60Eli Lilly's Lebanon, Indiana facility, which produces GLP-1 ingredients, is part of the PreCheck program. — Faster scaling of GLP-1 production addresses a critical global supply shortage for some of the world's most valuable drugs.
+0.50Regeneron and Fujifilm Biotechnologies are among the first seven companies selected for the FDA's accelerated facility review program. — Provides a regulatory tailwind for these specific companies to expand their domestic biologics production more efficiently.
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The PreCheck program requires facilities to address market supply gaps or unmet medical needs to be eligible. — Signals a strategic FDA priority to prioritize drugs with high clinical or market urgency over general production.
+0.20Which stocks this story touches
Selected for FDA pilot program that could accelerate manufacturing facility reviews by up to 14 months.
Included in the FDA PreCheck program to expedite the readiness of its new New York manufacturing site.
Fujifilm's biotech facility is part of the FDA pilot, potentially speeding up operational readiness and customer approvals.
Selected as one of the first seven companies for the FDA's facility review acceleration pilot.
Mentioned as a customer of Fujifilm's facility which is benefiting from an expedited FDA review process.
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Fox Business
19h ago
