FDA accepts for review a Theratechnologies BLA for ibalizumab as a treatment for multidrug resistant human immunodeficiency virus-1.
FDA accepts for review a Sunovion Pharmaceuticals supplemental NDA for the expanded use of Latuda (lurasidone HCl) in children and adolescents with ma...
FDA approves an Illumina PMA for its Extended RAS Panel, a next-generation sequencing kit that is intended to be used on the Illumina MiSeqDx System t...
FDA issues a draft guidance on Product Identifier Requirements Under the Drug Supply Chain Security Act Compliance Policy that delays enforcement of ...
In observance of the Fourth of July (Independence Day) holiday in the U.S., FDA Webview closes its news operations until Monday, July 10.
CBER says the number of biological and blood product deviation reports entered into its database increased 10% in FY 16 over FY 15.
FDA clears a Thermo Fisher Scientific 510(k) for its microbroth dilution plate for antimicrobial susceptibility of Gram negative organisms.
FDA announces plans and tactics to eliminate the orphan drug designation backlog and speed reviews of new requests.