FDA issues two draft guidances to help prevent branded drug companies from using shared system REMS negotiations to block generic entry.
FDA commissioner Scott Gottlieb says the agency is looking for additional steps it can take to mitigate the effect of drug shortages and help prevent ...
FDA approves a MicroVention PMA for the LVIS and LVIS Jr. stents for stent-assisted coil embolization of intracranial aneurysms.
Nektar Therapeutics files an NDA for NKTR-181, an analgesic opioid molecule that the company says exhibits a reduced incidence of specific side effect...
FDA makes available an International Council for Harmonization draft guidance entitled Q12 Technical and Regulatory Considerations for Pharmaceutical ...
FDA grants Genea Biocells an orphan drug designation for GBC0905 and its use in treating facioscapulohumeral muscular dystrophy.
FDA releases a draft guidance to help sponsors with the premarket assessment of a drugs effect on blood pressure.
FDA publishes an International Conference on Harmonization draft guidance on technical and regulatory considerations for drug product lifecycle manage...