Two stakeholders make recommendations for improving an FDA draft guidance on clinical trial considerations to support accelerated approval of oncology...
FDA sends iRhythm Technologies a Warning Letter that cites violations from an 8/22 agency inspection of the companys Zio heart monitor manufacturing s...
FDA proposes a regulation to replace the current Medication Guides with a one-page Patient Medication Information sheet.
FDA warns Woburn, MA-based Advanced Compounding Solutions about multiple violations in its production of unapproved and misbranded compounded drugs.
FDA accepts for priority review a Bristol Myers Squibb NDA for repotrectinib and its use for treating patients with ROS1-positive locally advanced or ...
FDA approves Blue Earth Diagnostics Posluma (flotufolastat F 18) injection, a prostate-specific membrane antigen-targeted positron emission tomography...
A developer of drugs to treat neovascular age-related macular degeneration raises issues with an FDA draft guidance on developing drugs for the condit...
Federal Register notice: FDA releases a draft guidance entitled Diabetes Mellitus: Efficacy Endpoints for Clinical Trials Investigating Antidiabetic D...
