FDA says some patients may discontinue Tasigna after taking it for three years or more and remain in remission for up to 96 weeks.
FDA says it will no longer grant orphan drug designation to most drugs for pediatric subpopulations of common diseases.
CDRH and CBER propose a voluntary medical device quarterly summary malfunction report for devices in certain program codes.
FDA issues a draft guidance on how it will issue an information request and/or discipline review letter to ANDA applicants.
FDA approves La Jolla Pharmaceuticals Giapreza injection for intravenous infusion to increase blood pressure in adults with septic or other distributi...
FDA warns Canadas Deserving Health International about CGMP violations in its manufacturing of homeopathic sterile eye drops.
FDA removes a Boxed Warning about asthma-related death from labels of medicines containing both an inhaled cortico steroid and a long-acting beta agon...
Physio-Control recalls its defibrillation electrodes due to incorrect placement instructions for infants that were depicted on artwork.