House Energy and Commerce Committee Republicans blocked an effort by Democrats to compel HHS secretary Robert F. Kennedy Jr. to testify before Congres...
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...
FDA selects investigational cholesterol and cancer drugs from Merck for expedited regulatory reviews under its Commissioner's National Priority Vouche...
FDA issues a Warning Letter to Catalents Bloomington, IN, drug manufacturing plant, citing significant manufacturing violations after investigators fo...
Diamond Research Foundation founder Beth Rosenshein petitions FDA to update Premarin labeling with information on the estrogen hormone equilin that is...
Two Mintz attorneys urge stakeholders to monitor FDA communications involving compliance and review carefully, looking for issues with information tha...
FDA approves GSKs Exdensur (depemokimab-ulaa), an ultra-long-acting biologic for severe asthma.
