FDA clears an SPR Therapeutics 510(k) for a broader indication for use for its Sprint Peripheral Nerve Stimulation System head, neck, and the front o...
FDA approves an Oyster Point Pharma NDA for Tyrvaya (varenicline solution) nasal spray 0.03 mg for treating signs and symptoms of dry eye disease.
FDA warns two Hennepin County Medical Center researchers they failed to submit INDs for their clinical investigations.
Sen. Richard Blumenthal (D-CT) tells a Bloomberg News reporter that he will likely oppose Duke University School of Medicine professor Robert Califfs ...
FDA warns Marcus Research Laboratory about CGMP deviations in its production of active pharmaceutical ingredients.
FDA sends Revance Therapeutics a complete response letter on its BLA for daxibotulinumtoxinA for Injection, indicated for treating frown lines, due to...
FDA issues Omeros a complete response letter on its BLA for narsoplimab as a treatment for hematopoietic stem cell transplant-associated thrombotic mi...
FDA reminds in vitro diagnostic manufacturers that the agency requires an institutional review board review for all device clinical investigations tha...