FDA clears a new indication for neurocare groups Apollo TMS therapy device to treat adolescents with major depressive disorder.
FDA approves a Johnson & Johnson NDA for Inlexzo (gemcitabine intravesical system) for adults with non-muscle invasive bladder cancer who do not respo...
FDA grants Greenwich LifeSciences fast track status for GLSI-100 for preventing breast cancer recurrences.
In a new crackdown on drug advertising, FDA orders pharmaceutical companies to remove any noncompliant ads and bring all promotional communications in...
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...
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...
