FDA announces several actions aimed at accelerating the development of treatments for serious mental illness, following a recent executive order from president Trump that directed federal health agencies to expand access to emerging therapies.
A recent FDA Warning Letter signals a broader regulatory focus on how drugmakers use artificial intelligence, according to a new analysis by law firm Morgan Lewis.
FDA announces several actions aimed at accelerating the development of treatments for serious mental illness, following a recent executive order from president Trump that directed federal health agencies to expand access to emerging therapies.
A recent FDA Warning Letter signals a broader regulatory focus on how drugmakers use artificial intelligence, according to a new analysis by law firm Morgan Lewis.
FDA issues AbbVie a complete response letter for its BLA for trenibotulinumtoxinE, an investigational, fast-acting botulinum toxin intended for aesthetic use.
FDA sends an untitled letter to Incyte Corp., warning that portions of the company’s consumer-facing Web site for Niktimvo (axatilimab-csfr) contain false or misleading promotional claims that violate federal law.
