FDA issues a Warning Letter to Catalents Bloomington, IN, drug manufacturing plant, citing significant manufacturing violations after investigators fo...
Two Mintz attorneys urge stakeholders to monitor FDA communications involving compliance and review carefully, looking for issues with information tha...
A Medshadow column raises concerns about FDAs stated efforts to allow some drugs to be approved based on a single pivotal trial.
FDA selects investigational cholesterol and cancer drugs from Merck for expedited regulatory reviews under its Commissioner's National Priority Vouche...
FDA approves GSKs Exdensur (depemokimab-ulaa), an ultra-long-acting biologic for severe asthma.
Sen. Ron Johnson (R-WI) demands that FDA turn over records related to an internal review that linked Covid-19 vaccinations to the deaths of at least 1...
FDA publishes a guidance clarifying how it evaluates real-world data to determine if they are sufficient to provide real-world evidence for regulatory...
Diamond Research Foundation founder Beth Rosenshein petitions FDA to update Premarin labeling with information on the estrogen hormone equilin that is...