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FDA reminds companies and the public that they have until 9/19 to submit comments on a draft guidance entitled E21 Inclusion of Pregnant and Breastfee...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 releases two final guidances related to biosimilar development: One on comparative analytical assessments, and the other on classification categor...
Kimberly-Clark agrees to pay $40 million under a deferred prosecution agreement to resolve a criminal charge that it sold adulterated MicroCool surgic...
Former FDA commissioner Scott Gottlieb warns that HHS secretary Robert F. Kennedy Jr. may attempt to use a forthcoming HHS report on autism to challen...
