FDA clears an Atraverse Medical 510(k0 for its Hotwire radiofrequency guidewire, a device that enables zero exchange left-heart access.
Abbott recalls (Class 1) its HeartMate 3 LVAS after reviewing complaints that identified blood or air leakages.
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...
