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FDA warns Uruguays Grupo Quimico SRL about CGMP violations in its work as a contract testing laboratory for drug companies.[ Price : $8.95]
Federal Register notice: FDA announces that it issued Day One Biopharmaceuticals a priority review voucher for its recently approv...[ Price : $8.95]
FDA clears a Qiagen 510(k) for the QIAstat-Dx Respiratory Panel Plus syndromic test for clinical use in diagnosing upper respirato...[ Price : $8.95]
FDA warns Azusa, CA-based Woodward Laboratories about CGMP violations in its production of finished drugs.[ Price : $8.95]
United Therapeutics asks FDA not to approve a Liquidia NDA for Yutrepia because the sole supplier of active pharmaceutical ingredi...[ Price : $8.95]
A California federal court tosses a shareholder class action suit claiming that AcelRx deliberately used marketing materials for i...[ Price : $8.95]
FDA issues a complete response letter for a Dynavax sBLA for a new indication for its Heplisav-B hepatitis vaccine.[ Price : $8.95]
FDA clears an Indica Labs 510(k) for HALO AP Dx, a digital pathology platform that the company says enables slides to be reviewed ...