FDA recommends that companies making transmucosal buprenorphine drugs indicated to treat opioid dependence revise the labeling to indicate there is no...
FDA approves Neurocrine Biosciences Crenessity to be used with glucocorticoids to control androgen in adult and some pediatric patients with classic c...
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.
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.
FDA posts a six-item Form FDA-483 that led to a 12/19 Warning Letter to Mylan Laboratories citing its Pradesh, India manufacturing facility.
FDA approves Checkpoint Therapeutics Unloxcyt to treat some squamous cell cancer patients.
