FDA issues a draft guidance to help ensure that information is available to patients and health care professionals to clearly communicate the benefits...
Federal Register notice: FDA withdraws the approval of Ivax Pharmaceuticals ANDA for chloramphenicol capsules (250 mg) after the company requested the...
Federal Register notice: FDA sends to OMB a new information collection entitled Pharmaceutical Voluntary Consensus Standard Recognition.
Reuters reports that the Department of Justice has opened a criminal investigation into Cassava Sciences over allegations it manipulated results in a ...
FDA approves Bavarian Nordics fill and finish facility in Denmark to manufacture its Jynneos smallpox/monkeypox vaccine.
FDA publishes a guidance with recommendations on including patients who have not received available therapy in non-curative settings.
FDA clears a Viz.ai 510(k) for its Viz Subdural (SDH), an algorithm that uses artificial intelligences to automatically detect subdural hemorrhages.
FDA approves an additional indication for GlaxoSmithKlines Benlysta to treat children with active lupus nephritis who are receiving standard therapy.