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 ...
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

Study: FDA’s expedited programs play increasing role in bringing novel drugs to market

Expedited development and review programs established by the US Food and Drug Administration (FDA) have a growing role in bringing drugs and biologics to market, with novel orphan and nonorphan ...
Medical Xpress

FDA unveils drugs to receive expedited review in support of 'national priorities'

The Food and Drug Administration on Thursday announced the first round of experimental drugs that will receive drastically expedited reviews at the agency, part of an effort to prioritize medicines ...
Fierce Pharma

FDA, UK drug regulator deepen transatlantic ties with new liaison program

The United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) and the U.S. | The program looks to support ...
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 ...
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Neuren Pharmaceuticals shares FDA meeting feedback on NNZ-2591 clinical programs

Yesterday afternoon, Neuren Pharmaceuticals Ltd (ASX: NEU) shared feedback from recent US FDA meetings on its NNZ-2591 clinical programs. Neuren said it received constructive guidance for its ...