FDA warns Greeces Rontis Hellas about Quality System and Medical Device Reporting violations in its production of a balloon catheter.
FDA approves Bristol Myers Squibbs Opdivo Qvantig subcutaneous injection for several cancer indications.
FDA approves Novo Nordisks Alhemo as a prophylaxis for some hemophilia patients.
FDA approves a new indication for Lillys Zepbound to treat some obese patients with obstructive sleep apnea.
FDA says Astellas has recalled one lot each of its Prograf and Astagraf transplant medications that may contain empty capsules.
FDA says Endo USA has recalled its Adrenalin Chloride Solution that predates the Federal Food, Drug, and Cosmetic Act and was never submitted for FDA ...
FDA warns four companies it says are marketing unapproved copies of popular weight loss drugs.
FDA publishes an updated Global Unique Device Identification Database guidance.