Bristol-Myers Squibb's (BMS) combination hypertension treatment Avalide should only be approved in the first-line treatment setting when the risks are outweighed by clinical need, according to clinical review documents released by the FDA. Read More
The FDA's Vaccines and Related Biological Products Advisory Committee will discuss lowering the minimum age for users of MedImmune's influenza vaccine FluMist at its May 16 meeting, the agency announced. Read More
A new report finds that most Americans think the FDA should have more authority over drug companies to enhance drug safety comes as Congress discusses several bills that would change the agency's standards. Read More
Austria-based Sanochemia Pharmazeutika violated quality system regulations (QSRs) by failing to maintain procedures to prevent contamination of its Fluorognost HIV assays, according to an FDA warning letter.