Federal Register: FDA makes available a final guidance on osteoporosis drug nonclinical studies.
A new study shows that FDA and European Medicines Agency reviewers have a high concordance (9198%) in approving/rejecting new drug applications.
FDA approves Zimmer Biomet Spines The Tether Vertebral Body Tethering System for treating idiopathic scoliosis.
Federal Register notice: FDA seeks comments on an information collection extension for the guidance on dear doctor letters.
FDA approves AbbVies Rinvoq (upadacitinib), a 15 mg, once-daily oral Janus kinase inhibitor and follow-on therapy to its blockbuster rheumatoid arthri...
FDA approves an expanded indication for several transcatheter heart valves to include patients with severe aortic valve stenosis who are at low risk f...
FDA issues a guidance to help drug sponsors design nonclinical bone studies to support approval of drugs and biologics intended to treat osteoporosis.
FDA says it is working in several ways with manufacturers to try to mitigate the current shortage of immune globulin products.