As FDA continues to evaluate the risk of suicidal thoughts or actions in patients taking glucagon-like peptide-1 receptor agonists, the European Medic...
FDA approves new safety labeling for Veloxis Pharmaceuticals Envarsus XR (tacrolimus), indicated for use with other medicines to help prevent organ re...
FDAer Susan Rosencrance tells the agencys Generic Drug Forum that FDA has chosen nine applicants to participate in a Quality Maturity Management evalu...
Federal Register notice: FDA determines that UCBs Kemstro (baclofen) orally disintegrating tablets, 10 mg and 20 mg, were not withdrawn from sale for ...
Federal Register notice: FDA determines that Pfizers Vistaril (hydroxyzine pamoate) oral suspension, 25 mg/5 mL, was not withdrawn from sale for reaso...
Oncolytics Biotech asks FDA for a 2nd quarter Type C meeting to agree on the design and objectives for a registration-enabling trial of its pelareorep...
FDA releases the form FDA-483 with six observations from an inspection at the Cipla API and drug manufacturing facility in Ragaid, Maharashtra, India.
FDA grants breakthrough device designation to a Roche blood test intended to aid in a diagnosis of Alzheimers disease based on amyloid pathology.
