Federal Register notice: FDA seeks comments on an information collection extension for Deeming Tobacco Products To Be Subject to the FD&C Act (OMB Con...
FDA approves a Merck supplemental NDA for use of its Keytruda (pembrolizumab) plus axitinib (Pfizers Inlyta) for the first-line treatment of patients ...
Federal Register notice: FDA announces a 6/19 meeting of its Circulatory System Devices Panel of the Medical Devices Advisory Committee to review safe...
Alvogen recalls two lots of fentanyl transdermal system 12 mcg/h transdermal patches due to a labeling error.
FDA announces that the National Academies of Science, Engineering, and Medicine (NASEM) is conducting a study to examine the clinical utility of treat...
FDA accepts a Molecular Templates IND application for MT-5111, an engineered toxin body targeting HER2-positive solid tumors.
FDA Review posts the Federal Register notices for the week ending 4/19/2019.
FDA Review posts product approval summaries for the week ending 4/19.