While a new facility setup program aimed at encouraging onshoring received a positive reception at a recent meeting, industry ...

The Food and Drug Administration is announcing the first round of drugs that will receive drastically expedited reviews at ...

The FDA has declared a Novo Nordisk plant, key to drug manufacturing for some biotechs, out of compliance, which could delay ...

The US Food and Drug Administration on Thursday announced the first drug manufacturers that will receive expedited reviews as part of a new initiative to reward companies for acquiescing to the Trump ...

Shares of Revolution Medicines, Disc Medicine, and Regeneron Pharmaceuticals rose in after-hours trading on Thursday after ...

The FDA has named the first nine medications selected for its national priority review voucher program, which aims to shorten drug review timelines to ...

The FDA named the first nine products to undergo a new expedited review process that takes 1 to 2 months, the agency ...

Aug. 7 (UPI) --The U.S. Food and Drug Administration announced Thursday it is launching the "FDA PreCheck" program in order to help construct drug manufacturing sites in the United States. "Our ...

Applicants can request this priority review by following the procedures outlined in FDA’s Manual of Policies and Procedures (MAPP) 5240.3, Prioritization of the Review of Original ANDAs, Amendments, ...

The U.S. Food and Drug Administration said on Friday that it has launched a new pilot program to speed up the review process for generic drugs that are tested and manufactured entirely in the United ...

The Priority Review program is a new initiative launched by the current administration. It was first announced in June of ...

The FDA launched a new voucher program to fast-track reviews, naming nine experimental drugs for cancer, diabetes, addiction, ...