FDA accepts a Corcept NDA for its relacorliant as a treatment for patients with platinum-resistant ovarian cancer.
Former FDA Digital Health Center of Excellence acting director Sonja Fulmer leaves the agency to accept a position at Mayo Clinic as senior director o...
FDA approves an expanded indication to include pediatric patients aged one and older for AstraZenecas Koselugo to treat some cases of neurofibromatosi...
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...
FDA reminds companies and the public that they have until 9/19 to submit comments on a draft guidance entitled E21 Inclusion of Pregnant and Breastfee...
