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...
FDA approves an expanded indication to include pediatric patients aged one and older for AstraZenecas Koselugo to treat some cases of neurofibromatosi...
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...
