FDA grants Ardelyx appeal of a complete response letter for its Xphozah to treat adult patients with chronic kidney disease on dialysis with hyperphos...
FDA Webview posts the Federal Register notices that published during our annual holiday break.
Advanced Bionics agrees to pay more than $12 million to the federal government and participating Medicaid states to resolve a whistleblowers suit alle...
FDA approves an On Target Laboratories supplemental NDA for Cytalux (pafolacianine) to help surgeons in identifying lung cancer lesions.
FDA approves a Ferring Pharmaceuticals BLA for Adstiladrin (nadofaragene firadenovec-vncg), a non-replicating adenoviral vector‑based gene thera...
FDA says it is holding a 1/26/2023 meeting of its Vaccines and Related Biological Products Advisory Committee to consider whether current Covid-19 vac...
Congress passes S 3905 Preventing Organizational Conflicts of Interest in Federal Acquisition Act that aims to curb government contractors from having...
Federal Register notice: FDA corrects an 8/20 notice to reflect the correct dates that the support and requirement were to begin for version 1.7 of th...
