FDA grants Omeros an orphan drug designation for OMS721 for treating Immunoglobulin A (IgA) nephropathy.
FDA warns healthcare professionals about hypersensitivity reactions related to ImprimisRxs curcumin (a component of the spice turmeric) compounded wit...
A Utah federal judge enters a consent decree of permanent injunction against Isomeric Pharmacy Solutions (Salt Lake City), co-owners William O. Richar...
FDA grants Applied Genetic Technologies an orphan drug designation for its unidentified gene therapy product candidate for treating X-linked retinitis...
FDA clears a Standard Bariatrics 510(k) for the Standard Clamp, a disposable laparoscopic surgical clamp that is intended to assist surgeons performin...
Alliance for a Stronger FDA explains how tobacco user fees skew the case for raising taxpayer-funded budget levels for FDAs annual congressional appro...
Daiichi Sankyo says that it and Forest are settling claims against them alleging their olmesartan products caused sprue-like enteropathy and other gas...
Federal Register notice: FDA announces the availability of a draft guidance on Child-Resistant Packaging Statements in Drug Product Labeling.