Federal Register Final Rule: FDA amends the animal drug regulations to reflect recent application-related actions for NADAs and ANADAs.
FDA accepts for priority review a Pfizer NDA for dacomitinib, a pan-human epidermal growth factor receptor tyrosine kinase inhibitor, for first-line t...
FDA clears an Aesku Group 510(k) for its Aeskuslides nDNA (Crithidia luciliae) assay and its use on the companys new Helios Automated IFA System.
Federal Register Final Rule; technical amendment: FDA amends certain medical device regulations to correct editorial issues, such as typographical err...
Endo agrees to extend for 180 days a stay in its suit against FDA over agency policy in compounding using bulk drug substances.
FDA panel members are divided on CLIA waivers for using glucose meters to measure blood glucose in capillary blood in patients receiving intensive med...
FDA releases the establishment inspection report from its 2017 inspection at the Celltrion Yeonsgu-go Plant 1 in Inchon, Korea.
FDA approves a W. L. Gore expanded indication for its Gore Cardioform Septal Occluder for patent foramen ovale (PFO) closure to prevent recurrent isch...