FDA approves an expanded indication to include pediatric patients aged one and older for AstraZenecas Koselugo to treat some cases of neurofibromatosi...
FDA warns Jigani, Karnataka, India-based Hikal Limited about CGMP deviations in its production of active pharmaceutical ingredients.
FDA warns Detroit, MI-based medical oncologist Shirish Gadgeel about bioresearch monitoring violations in his conduct of three clinical investigations...
Eli Lilly hires former CBER Office of Therapeutic Products (OTP) deputy director Rachael Anatol, who was removed from her agency post and placed on ad...
Lexicon Pharmaceuticals submits new clinical data to FDA that attempts to advance its stalled NDA for its diabetes drug Zynquist (sotagliflozin).
Capricor Therapeutics posts its response to an FDA complete response letter for Bytreldo since the agency published the letter publicly, but not the c...
NRx Pharmaceuticals petitions FDA seeking a ban on all ketamine products formulated with the preservative benzethonium chloride, arguing that the subs...
The 7th Circuit Court of Appeals affirms, although for different legal reasons, a federal district court ruling rejecting a False Claims Act retaliati...
