FDA approves an AstraZeneca BLA for Saphnelo (anifrolumab-fnia) for treating adult patients with moderate to severe systemic lupus erythematosus.
Federal Register final rule: FDA issues a final rule to amend its medical product intended use regulations.
FDA defends the accelerated approval process in the wake of Biogens controversial Alzheimers approval and a new BMJ report that since the programs inc...
FDA grants Biofourmis a breakthrough device designation for BiovitalsHF, a software medical application that is intended to augment guideline-directed...
FDA Review posts the latest Federal Register notices for the week ending 7/30/2021.
Federal Register notice: FDA has set the medical device user fee rates for fiscal year 2022.
Federal Register notice: FDA announces a 10/7 Antimicrobial Drugs Advisory Committee meeting to discuss Takeda's maribivir.