FDA commissioner Marty Makary reinstates CBER director Vinay Prasads previous additional duties as the agencys chief medical and scientific officer.
FDA publishes a draft guidance to assist in developing non-opioid analgesics to treat chronic pain.
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...
