FDA denies a BioDelivery Sciences petition seeking agency actions to restrict follow-on products citing Belbuca as the reference-listed drug.
The American Medical Association bestows its Award for Outstanding Government Service on CBER director Peter Marks for his Covid-19 leadership efforts...
Federal Register notice: FDA updates its current listing of medical devices that have received an Emergency Use Authorization during the Covid-19 pand...
Provention Bio refiles its BLA for teplizumab for the delay of clinical Type 1 diabetes in at-risk individuals.
FDA approves Bristol-Myers Squibbs Opdualag to treat some adults and pediatric patients with melanoma.
The Association for Accessible Medicines gives its views on Department of Justice and Federal Trade Commission efforts to modernize merger enforcement...
FDA says it has reached an agreement with representatives of the medical device industry on the MDUFA 5 reauthorization provisions.
FDA clears a Quantum Surgical 510(K) for its Epione, described as a robotic-assisted device designed to plan, target, deliver and confirm tumor ablati...