Leveraging Development Strengths Drives Therapies to Market

The agency’s newly issued letter to Sanofi amends one sent in December 2024, and stems from inspections at its Massachusetts drug manufacturing facility in June and July 2024.

This latest fast track designation marks the second such designation by FDA for J&J’s tau-directed investigational therapies for treating Alzheimer’s disease.

The approval makes HYQVIA [Immune Globulin Infusion 10% (human) with Recombinant Human Hyaluronidase] the first and only facilitated subcutaneous immunoglobulin to be approved in Japan to treat these disorders.

FDA provides recommendations for those interested in participating in the agency's Advanced Manufacturing Technologies Designation Program.

FDA is reopening the comment period for the Federal Register Notice, “Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-on Recombinant Peptide Products: Establishment of a Public Docket: Request for Information and Comments”, until March 3, 2025.

The approval of Hikma Pharmaceuticals’ liraglutide injection marks the first generic version of Victoza, a GLP-1 receptor agonist.