FDA Review has posted the Federal Register notices for the week ending 10/8/2021.
FDA Review posts product approval summaries for the week ending 10/8/2021.
FDA approves a ChemoCentryx NDA for Tavneos (avacopan) as an add-on treatment for adult patients with severe active anti-neutrophil cytoplasmic autoa...
FDAs Antimicrobial Drugs Advisory Committee votes 17-0 to recommend approval of Takedas maribavir to treat cytomegalovirus infection in the post-trans...
Federal Register notice: FDA announces a final guidance entitled Surgical Staplers and Staples for Internal Use Labeling Recommendations.
Federal Register notice: FDA issues a final order to reclassify surgical staplers for internal use from Class 1 into Class 2 and subject to premarket ...
FDA outlines a new pilot program on using novel excipients with the intent to increase their use in drug development, especially if they have potentia...