FDA warns Uruguays Grupo Quimico SRL about CGMP violations in its work as a contract testing laboratory for drug companies.
Federal Register notice: FDA announces that it issued Day One Biopharmaceuticals a priority review voucher for its recently approved pediatric disease...
FDA clears a Qiagen 510(k) for the QIAstat-Dx Respiratory Panel Plus syndromic test for clinical use in diagnosing upper respiratory infections and co...
FDA warns Azusa, CA-based Woodward Laboratories about CGMP violations in its production of finished drugs.
United Therapeutics asks FDA not to approve a Liquidia NDA for Yutrepia because the sole supplier of active pharmaceutical ingredients to Liquidia is ...
A California federal court tosses a shareholder class action suit claiming that AcelRx deliberately used marketing materials for its Dsuvia opioid pai...
FDA issues a complete response letter for a Dynavax sBLA for a new indication for its Heplisav-B hepatitis vaccine.
FDA clears an Indica Labs 510(k) for HALO AP Dx, a digital pathology platform that the company says enables slides to be reviewed from any location as...
