Reactions to a Congressional report on FDAs 2021 controversial review and approval of Biogens Alzheimers drug Aduhelm sharply criticize the approval a...
FDA publishes an International Council for Harmonization guideline on a clinical electronic structured protocol.
President Biden signs into law FDAs fiscal year 2023 spending bill as part of the end-year omnibus legislation (HR 2617, Consolidated Appropriations A...
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...
