FDA grants SIRPant Immunotherapeutics an orphan drug designation for SIRPant-M, an autologous macrophage therapy for treating T-cell lymphoma.
FDA reviewers say that making an assessment on the clinical meaning of complicated data presentations in a Merck NDA resubmission for chronic cough me...
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...
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.
