Eli Lilly, Regeneron among first companies selected for FDA initiative to speed review of new manufacturing facilities

Eli Lilly and Regeneron are among the first seven companies the FDA has selected for its PreCheck Pilot Program, CNBC has ...

FDA launches pilot program to speed up early drug trials

The agency says pairing drug sponsors with research institutions could cut development timelines by 6 to 12 months ...
Fierce Pharma

FDA selects Lilly, Regeneron, Fujifilm, 4 others for PreCheck Pilot Program

Biopharma giants Eli Lilly and Regeneron and rapidly growing contract manufacturers Fujifilm and Cellares are among the seven ...
TMCnet

FDA Selects Kyowa Kirin for PreCheck Pilot Program to Accelerate Manufacturing Timelines and Enhance Supply Chain Resilience

Strategic collaboration at Sanford, North Carolina facility, currently under construction, to optimize cGMP validation, accelerate time-to-market for complex biologics, and shore up U.S. medicine ...
NC Biotech

FDA selects 3 NC sites for pilot program to boost US biomanufacturing

The U.S. Food and Drug Administration selected three biopharma companies with manufacturing sites in North Carolina for a ...
STAT

FDA to launch pilot program to speed up early-stage clinical trials

WASHINGTON — Federal health officials announced a pilot program Monday to speed up early-stage clinical trials, which they ...
TMCnet

Kriya Selected for FDA PreCheck Pilot Program

Kriya Therapeutics, Inc. ("Kriya"), a biotechnology company developing durable medicines for chronic diseases, today announced it has been selected by the U.S. Food and Drug Administration (FDA) to ...
RAPS

FDA’s Biosimilars Workload: 57 Development Programs, $81M Spent in First Three Fiscal Years

A new independent analysis of the US Food and Drug Administration's (FDA) workload around biosimilars over the first three years shows how biosimilar development has slowly progressed as companies ...
Truckinginfo

FDA Program Will Put More RFID Tags in the Freight Stream

The Food and Drug Administration Monday announced an initiative to encourage the use of RFID by drug companies. Mark your calendar: June 30, 2026 (10:00 a.m. PDT). A 37.5% ownership interest in ...