The U.S. Food and Drug Administration (FDA) announced that it will fast-track review of nine experimental drugs.

This episode of Pharma Pulse covers Amazon and WeightWatchers’ partnership to deliver FDA-approved weight-loss medications, ...

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

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 ...

The FDA is experiencing rising delays in drug approvals, raising concerns about operational strain within the agency, according to an RBC Capital ...

"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 ...

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

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, ...

Sanofi's Tzield gains FDA's expedited review, promising rapid access to innovative treatment for type 1 diabetes and ...

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