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

Applicants can request this priority review by following the procedures outlined in FDA’s Manual of Policies and Procedures ...

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

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

Marketing and manufacturing practices for compounded GLP-1RA drugs have come under FDA scrutiny, prompting policy changes.

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 ...

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 ...

Now North Carolina newcomer OXB, a UK-based CDMO in cell and gene therapy, announced Oct.7 that it has acquired the former ...

Bhopal: Two drug manufacturing units in MP—one in Indore and the other in Dewas—have been instructed to halt production.

The U.S. Food and Drug Administration said on Friday it has launched a new pilot program to speed up the review process for ...