Federal Register notice: FDA determines that Eli Lillys Axiron (testosterone) transdermal metered solution, 30 mg/1.5 ml actuation was not withdrawn f...
FDA grants Revive Therapeutics an orphan drug designation for cannabidiol for preventing ischemia and reperfusion injury resulting from solid organ tr...
Federal Register notice: FDA seeks comments on a new proposed information collection entitled Web-Based Pilot Survey To Assess Allergy to Cosmetics in...
FDA issues an alert on a Kadesh recall of all lots of Puriton Eye Relief Drops due to non-sterile production conditions at the manufacturing facility.
FDA grants SpringWorks Therapeutics a fast track designation for nirogacestat, a selective gamma-secretase inhibitor under development for treating ad...
FDA approves a revised OTC version of Primatene Mist for a small group of asthma users.
FDA posts computer code for its MyStudies app so patients can input real-world data for clinical trials, registries, and other uses.
Federal Register notice: FDA makes available a draft guidance entitled Meta-Analyses of Randomized Controlled Clinical Trials to Evaluate the Safety o...