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 warns Indias Bhargava Phytolab about CGMP issues in its manufacturing of finished drugs and active pharmaceutical ingredients.
Axsome Therapeutics plans an NDA submission for AXS-05 (dextromethorphan-bupropion) in the second half of next year for treating Alzheimers disease ag...
Novo Nordisk petitions FDA to exclude its liraglutide from the agencys list of bulk drug substances that may be used by drug compounders.
