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.
Bayer withdraws its NDA for Aliqopa (copanlisib) for adult patients with relapsed follicular lymphoma who have received at least two prior systemic th...
Federal Register notice: FDA renews the Nonprescription Drugs Advisory Committee for an additional two years.
Former Becton Dickinson medical director Hooman Noorchashm petitions FDA to warn patients about the unknown and inadequately studied effect of FDA-reg...
FDA asks the Oncologic Drugs Advisory Committee whether Acrotech Biopharmas plan to complete a confirmatory trial for two cancer drugs years after the...