FDA approves CorMedixs Defencath (taurolidine and heparin) catheter lock solution to reduce catheter-related bloodstream infections in adult patients ...
FDA commissioner Robert Califf says the time is right to work on implementing recommendations in a Reagan-Udall Foundation report on post-market evide...
Baxter Healthcare recalls its Novum IQ Syringe Infusion Pump because the device may indicate an infusion is complete when it is not.
FDA says the Arizona federal court has approved a permanent injunction against Smart Womens Choice and its CEO to prevent them from illegally distribu...
Israels IceCure Medical says it is appealing an FDA denial of the companys de novo classification request for its ProSense cryoablation system for use...
Ascendis Pharma resubmits an NDA for TransCon PTH (palopegteriparatide) for treating adults with hypoparathyroidism.
FDA warns Chinas Ming Fai Industrial Co about QS violations in its production of ultrasound gel and probe cover products.
A lengthy FDA Warning Letter details issues at Indias Global Pharma Healthcare that led to contaminated ophthalmic drugs.
