FDA approves a Nevro Corp. PMA for its Senza System for treating chronic pain associated with painful diabetic neuropathy.
FDA Review posts the Federal Regiter notices for the week ending 7/16/2021.
FDA grants Pfizer/BioNTech a priority review (user fee action due 1/2022) for a BLA for their mRNA vaccine to prevent Covid-19 in individuals 16 years...
KorvaLabs requests that its emergency use authorization for the Curative SARS-Cov-2 (Covid-19) test be revoked because it is now using different EUA-a...
FDA clears a Dexcom 510(k) for its Dexcom Partner Web application programming interface to enable invited third-party developers to integrate real-tim...
FDA approves a Kadmon Pharmaceuticals NDA for Rezurock (belumosudil), a kinase inhibitor for treating certain adult and pediatric patients 12 years an...
FDAs Cardiovascular and Renal Drugs Advisory Committee votes against recommending approval for a FibroGen NDA for roxadustat, indicated for treating a...
Federal Register notice: FDA makes available a draft guidance entitled Draft Guidance for Cilastatin Sodium; Imipenem; Relebactam.