FDA approves Jazz Pharmaceuticals Rylaze as a part of a chemotherapy regimen for a common childhood cancer.
Vifor asks FDA to reconsider its decision to change the established names and active ingredients for iron-containing complex drugs.
FDA Review posts the Federal Register notices for the week ending 7/2/2021.
In observance of the Fourth of July (Independence Day) holiday in the U.S., FDA Webview closes its news operations until Tuesday, July 6.
Federal Register notice: FDA makes available a draft guidance entitled Cancer Clinical Trial Eligibility Criteria: Approach to Available Therapy in No...
FDA delays the review actions on two AbbVie supplemental NDAs for Rinvoq (upadacitinib), a JAK inhibitor for treating adults with active psoriatic art...
FDA posts a draft guidance on Sponsor Responsibilities Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence...
Federal Register notice: FDA seeks comments on a proposed information collection entitled Class II Special Controls for Human Immunodeficiency Virus ...