The latest Sedgwick recall index report details increases in drug and medical device recalls in the first quarter of 2023 over the fourth quarter of 2...
FDA grants Human Immunology Biosciences an orphan drug designation for felzartamab, an investigational agent for treating primary membranous nephropat...
Michigan members of the House of Representatives urge quick FDA action to address shortages of three chemotherapy drugs.
FDA approves a Pfizer NDA for its antiviral Paxlovid (nirmatrelvir tablets and ritonavir tablets) for treating mild-to-moderate Covid-19 in adults who...
Federal Register notice: FDA releases a draft guidance entitled Generally Accepted Scientific Knowledge in Applications for Drug and Biological Produc...
Federal Register notice: FDA makes available a final guidance entitled Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Ans...
An FDA Notice of Violation says Fairport, NY-based Regenerelle is marketing stem cell and exosome products without required drug and biologic approval...
Integra LifeSciences recalls all products manufactured at its Boston, MA facility due to inadequate endotoxin testing.
