FDA reiterates warning against hand sanitizers containing methanol.
Endpoint News reports that FDA has rejected an Intercept Pharmaceuticals NDA for its obeticholic acid to treat NASH.
FDA approves ViiVs Rukobia for certain HIV patients.
Federal Register notice: FDA establishes a docket to solicit public comment on specific questions pertaining to the use of codeine for analgesia in ch...
A National Academies committee says compounded bioidentical hormone therapies are insufficiently regulated and pose a public health risk.
Federal Register notice: FDA sends to OMB an information collection extension for Reporting Associated With Animal Drug and Animal Generic Drug User F...
Two radiology professional societies say FDA is not ready to approve a pathway for authorizing autonomously functioning artificial intelligence in rad...
Three former FDA and HHS officials say there must be four safeguards in place to promote trust in any Covid-19 vaccine.