Eli Lilly and Regeneron selected for FDA pilot program to boost US drug manufacturing

Regulation
โดย Seeking Alpha·Read original
Summary · why it matters

Eli Lilly and Regeneron Pharmaceuticals are among seven drug companies selected by the US FDA for its PreCheck Pilot Program, which aims to improve US drug manufacturing capabilities. The program offers earlier FDA engagement and a more predictable regulatory pathway for companies planning to manufacture drugs for the US market. Other selected companies include Amneal Pharmaceutical and Kyowa Kirin.

Impact on stocks 4

Biotech & Genomic Medicine · 4 stocks
Eli Lilly and Company
LLY
▲ PositiveRegulationrelevance

Selected for FDA PreCheck Pilot Program, improving US drug manufacturing capabilities with earlier FDA engagement.

Regeneron Pharmaceuticals Inc
REGN
▲ PositiveRegulationrelevance

Selected for FDA PreCheck Pilot Program, providing more predictable regulatory pathway for US manufacturing.

Kyowa Kirin Co., Ltd.
4151
▲ PositiveRegulationrelevance

Selected for FDA PreCheck Pilot Program, offering earlier FDA engagement and predictable regulatory pathway.