FDA clears a MiRus 510(k) for the MoRe-based Europa Pedicle Screw System, which the company says is the first cleared medical device with this new cla...
FDA warns the iMedDo Web site that it is selling unapproved and misbranded human and animal drugs.
FDA approves a Clarus Therapeutics NDA for Jatenzo (testosterone undecanoate), an oral testosterone capsule to treat men with certain forms of hypogon...
FDA clears an Innovative Neurological Devices 510(k) for the Cervella Cranial Electrotherapy Stimulator for treating anxiety, depression, and insomnia...
FDA proposes its first amendments to mammography facility regulations in over 20 years.
FDA warns Mariposa Labs about CGMP and other violations in its production of finished pharmaceuticals.
CDER clinical pharmacologists say they are working with stakeholders to develop computational models to achieve safe and effective dosing recommendati...
Celgene submits an NDA for ozanimod for treating adults with relapsing forms of multiple sclerosis.