US FDA launches program to boost domestic drug manufacturing

By Ahmed Aboulenein WASHINGTON, Feb 1 (Reuters) - The U.S. Food and Drug Administration on Sunday began accepting requests to ...
JD Supra

New FDA Approach to Drug Prices Adds Uncertainty to Drug Approval Process

FDA’s focus on playing a direct role in lowering drug prices may provide opportunities for some pharmaceutical companies to seek a regulatory advantage. But it also places enormous pressure on ...
Healio

FDA approvals, mixed efficacy results mark FcRn blockade pipeline in rheumatology

Medications targeting the neonatal fragment crystallizable receptor have gained attention due to multiple recent FDA ...
JD Supra

FDA PreCheck Pilot Program Launches, Clearing a Smooth Path to Approval

On February 1, 2026, the Food and Drug Administration (FDA) officially started accepting requests to participate in the FDA PreCheck pilot ...
Fierce Pharma

FDA emphasizes drug ingredients, production pledges as it debuts PreCheck manufacturing program

The FDA laid out the qualifications a site would need to qualify for PreCheck on a webpage where companies can also submit requests to take part in the program. Companies are limited to one submission ...
Marijuana Moment

West Virginia And Mississippi Lawmakers Approve Psychedelics Bills To Fund Ibogaine Trials Toward FDA Approval

The West Virginia House of Delegates and Mississippi House of Representatives have both approved bills to support research in ...

Realizing The Promise: How Personalized Gene Editing Can Treat Ultra-Rare Diseases

With a shared purpose, we can realize the true promise of CRISPR and improve healthcare, providing hope to more patients with ...
Public Broadcasting Service (PBS)

FDA's new expedited drug program raises legal questions and concerns

The FDA commissioner's effort to shorten the review of drugs favored by the Trump administration is causing alarm across the agency, stoking worries that the plan may run afoul of legal, ethical and ...

Hims GLP-1 Weight Loss: What Consumers Should Know About the Reported $49 Compounded Semaglutide Pill, Novo Nordisk Response, and Telehealth Prescriptio…

Disclaimer: This article is for informational purposes only. It is not medical advice. Weight management concerns should be ...

FDA launches program to boost domestic drug manufacturing

The U.S. Food and Drug Administration on Sunday began accepting requests to participate in its PreCheck pilot program, designed to boost domestic drug supply by speeding up construction and review of ...

FDA opens fast-track program to speed U.S. drug plant construction

FDA PreCheck pilot aims to speed U.S. pharma plant construction and approvals for critical medicines with earlier feedback.

Legal questions swirl around FDA's new expedited drug program, including who should sign off

The Food and Drug Administration commissioner's effort to drastically shorten the review of drugs favored by President Donald Trump's administration is causing alarm across the agency, stoking worries ...