FDA approves a Trevena NDA for Olinvyk (oliceridine), an opioid agonist for managing moderate to severe acute pain in adults.
FDA approvea a Guardant Health PMA for the Guardant360 CDx assay, the first liquid biopsy companion diagnostic that also uses next-generation sequenci...
Becton Dickinson predicts a six-month delay in submitting a 510(k) for modifications to its troubled Alaris infusion pump.
Gilead Sciences files an NDA for Veklury (remdesivir), indicated for treating patients with Covid-19.
FDA makes available a guidance entitled Bioresearch Monitoring Technical Conformance Guide.
Federal Register notice: FDA announces an 8/31 online Pulmonary-Allergy Drugs Advisory Committee meeting.
Federal Register notice: FDA makes available a draft guidance entitled Drug-Drug Interaction Assessment for Therapeutic Proteins.
FDA makes available a guidance entitled Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act; Content and For...