YourBio Health names former FDA commissioner Stephen Hahn as its interim chief medical officer.
FDA makes three revisions to a guidance containing questions and answers on developing ANDAs during the Covid-19 pandemic.
FDA and the Duke-Margolis Center for Health Policy schedule a public meeting on the agencys plan to reconsider the need for mandatory opioid prescribe...
FDA clears a joimax 510(k) for the EndoLIF Delta Cage and EndoLIF DoubleWedge Cage, intended for intervertebral body fusion procedures.
FDA warns Genesis Ultra Slim that its Ultra Slim Gold is a misbranded unapproved new weight loss drug.
Federal Register notice: FDA seeks nominations for members to serve on the Tobacco Products Scientific Advisory Committee.
Federal Register notice: CDER announces its Novel Excipient Review Pilot Program and seeks initial proposals by 12/7.
Azurity Pharmaceuticals recalls one lot of Firvanq (vancomycin hydrochloride for oral solution) 50 mg/mL kit because some products in the affected lot...