FDA grants Bracco Imaging a fast-track designation for its BR55 (perfluorobutane/nitrogen lipopeptide-coated microbubbles) injection for detecting are...
FDA warns Chinas Imperial Palace Commodity about CGMP violations in its manufacturing of over-the-counter drugs.
FDA warns Pompano Beach, FL-based BioStem Life Sciences that it is illegally marketing cellular products that also reflect CGMP violations.
An FDA safety alert on certain diabetes devices that rely on a smartphone to deliver critical safety alerts warns that these may malfunction at times.
A Bloomberg Law report says New York is the latest state to indicate an interest in the FDA pathway to import lower-cost drugs from Canada.
Kura Oncology and Kyowa Kurin say they expect to submit a ziftomenib NDA to FDA in the second quarter of 2025.
FDA grants Acrivon Therapeutics a breakthrough device designation for the ACR-368 OncoSignature assay, a multiplex immunofluorescence assay for identi...
Baxter Healthcare Corporation recalls its Life2000 Ventilator System due to a nonconforming battery charger.
