biologics News & Analysis

Eli Lilly (LLY) selected for FDA's PreCheck pilot program

Eli Lilly (LLY) and Regeneron (REGN) are among the first seven companies selected for the FDA's PreCheck pilot program aimed at accelerating reviews of new pharmaceutical manufacturing facilities. The initiative allows regulators to review facilities during construction, potentially saving companies up to 14 months in review time. Lilly's facility in Lebanon, Indiana, and Regeneron's $2 billion site in Saratoga Springs, New York, are included in the program. This effort targets domestic drug production and involves companies producing biologic drugs and genetic medicines.