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

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

A gene therapy from Regeneron, a pancreatic cancer medicine from Revolution Medicines and a porphyria drug from Disc Medicine ...

"Infertility treatment heads first drugs on FDA’s new priority review scheme" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand.

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 ...

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, ...

Slapped with the most severe post-inspection classification, the state of Novo Nordisk’s Indiana manufacturing site could ...

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

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