FDA begins next month accepting requests from drug and biologics sponsors seeking to participate in the fifth and final year of its Chemistry, Manufac...
A bipartisan Senate bill intended to give patients and health care providers more information about where prescription drugs are manufactured loses tw...
HHS secretary Robert F. Kennedy Jr.'s vaccine skepticism remarks this week likely complicate Heidi Overtons upcoming confirmation hearing to lead FDA....
FDA grants Eli Lilly full approval for the combination use of Inluriyo (imlunestrant) with Verzenio (abemaciclib) in certain adults with estrogen rece...
A coalition of 20 state attorneys general urge the Trump administration to tighten or suspend an FDA import program, alleging that Chinese suppliers a...
FDA cites Connecticut outsourcing facility Brookfield Medical/Surgical Supplies for inadequate investigations involving 13 out-of-specification potenc...
A KFF Health News report documents hundreds of FDA-mandated postmarket studies whose reports are listed as delayed.
FDA issues a strategy document summarizing discussions at a 2025 workshop on developing interchangeable biosimilar products.
