Axsome Therapeutics expects to receive a complete response letter on its NDA for migraine drug AXS-07 (meloxicam-rizatriptan) due to FDA-identified ch...
Eleven defendants, including the founders of several lab companies, plead guilty in a $300 million scheme to pay kickbacks to induce medical professio...
FDA expands the approval of Gilead Sciences Veklury (remdesivir) to include treating Covid-19 pediatric patients 28 days of age and older weighing at ...
CDERs Office of New Drugs says it will convene its Cardiovascular and Renal Drug Advisory Committee to hear an appeal from Ardelyx of a complete respo...
FDA Review posts the Federal Register notices for the week ending 4/22/2022.
FDA Review posts product approval summaries for the week ending 4/22/2022.
Federal Register notice: FDA makes available a final guidance entitled Drug Products, Including Biological Products, That Contain Nanomaterials.