Federal Register notice: FDA intends to inactivate the registration of establishments that manufacture human cells, tissues, or cellular or tissue-bas...
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A developer of drugs to treat neovascular age-related macular degeneration raises issues with an FDA draft guidance on developing drugs for the condit...
FDA accepts for priority review an Iovance Biotherapeutics BLA submission for lifileucel, a tumor infiltrating lymphocyte therapy for treating patient...
Janssen submits an NDA to FDA for an investigational combination of Opsumit and Cialis to treat some adults with pulmonary arterial hypertension.
