FDA accepts for review a Shorla Oncology NDA for SH-105 for treating breast and ovarian cancer.
Canadian officials say they will act to prevent Floridas importation of drugs from that country to cause a shortage in Canada.
FDA publishes an ICH guidance on evaluating the viral safety of biotechnology products derived from human or animal cell lines.
FDA says it has not been able to establish a causal connection between suicidal ideation and drugs like Ozempic and Wegovy and is continuing to review...
Four major stakeholder groups air their disagreement with an FDA revised draft guidance on firms communicating scientific information on unapproved us...
FDA clears a Zeta Surgical 510(k) for its Zeta Cranial Navigation System.
Busse Hospital Disposables recalls its Tracheostomy Care Tray, Dressing Change Tray, and Tracheostomy Care Set in response to Nurse Assists 11/2023 re...
Federal Register notice: FDA makes available a draft guidance entitled Requests for Reconsideration at the Division Level Under GDUFA.
