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...
FDA reminds companies and the public that they have until 9/19 to submit comments on a draft guidance entitled E21 Inclusion of Pregnant and Breastfee...
FDA clears a Microbot Medical 510(k) for its Liberty Endovascular Robotic System, a single-use, remotely operated device for peripheral endovascular p...
A MAHA Commission report assessing the health of American children suggests a couple of ways in which FDA could improve the situation.
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...
