Federal Register notice: FDA makes available a draft guidance entitled Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products...
FDA warns Denver, CO-based Optikem about CGMP violations in its production of finished drugs.
CBER publishes an updated 2024 guidance agenda with 20 listings.
Elevar Therapeutics says that after a meeting with FDA it is ready to resubmit its NDA for rivoceranib in combination with camrelizumab as a first-lin...
FDA grants Obsidian Therapeutics a fast track designation for OBX-115, a T cell immunotherapy in combination with a pharmacologically regulatable memb...
Federal Register notice: FDA grants an Emergency Use Authorization to the U.S. Centers for Disease Control and Prevention for its in vitro diagnostic ...
FDA grants Laboratory Corp. of America an Emergency Use Authorization for the Labcorp Monkeypox PCR Test Home Collection Kit.
Federal Register notice: FDA seeks comments on an information collection extension entitled Reclassification Petitions for Medical Devices 21 CFR Par...
