Mirati Therapeutics says its sitravatinib failed to meet the primary endpoint in the Phase 3 SAPPHIRE lung cancer study.
FDA publishes a guidance with recommendations to help manufacturers comply with the special controls related to non-clinical performance data for gyne...
FDA publishes a guidance with its recommendations on adjusting for covariates in the statistical analysis of randomized clinical trials in drug develo...
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Federal Register notice: FDA releases a draft guidance entitled Generally Accepted Scientific Knowledge in Applications for Drug and Biological Produc...
