FDA releases its latest batch of Warning Letters that includes Taka USA and Soluciones Cosmeticas.
FDA releases the first monthly spreadsheet submitted by Bayer on adverse events for its Essure birth control device.
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.