Human Drugs
Nabriva Antibiotic Approved for Pneumonia
FDA approves a Nabriva Therapeutics NDA for Xenleta (lefamulin) for treating adults with community-acquired bacterial pneumonia.
Federal Register
Latest Federal Register Notices
FDA Review posts the Federal Register notice for the week ending 8/16/2019.
FDA General
Product Approval Summaries
FDA Review posts product approval summaries for the week ending 8/16/2019.
FDA General
Since Our Last Issue ...
Industry news you may have missed since our last issue.
Federal Register
Panel to Discuss GSK NDA for OTC Nicotine Spray
Federal Register notice: FDA announces a 9/18 panel meeting on a GlaxoSmithKline NDA for the over-the-counter marketing of nicotine oral spray for wit...
Federal Register
Nonclinical Osteoporosis Drug Study Guide
Federal Register: FDA makes available a final guidance on osteoporosis drug nonclinical studies.
Human Drugs
FDA/EMA Study Examines Drug Approval Concordance
A new study shows that FDA and European Medicines Agency reviewers have a high concordance (9198%) in approving/rejecting new drug applications.
Medical Devices
Zimmers Spinal Tether OKd for Idiopathic Scoliosis
FDA approves Zimmer Biomet Spines The Tether Vertebral Body Tethering System for treating idiopathic scoliosis.
Federal Register
Info Collection Extension for Dear Doctor Letters
Federal Register notice: FDA seeks comments on an information collection extension for the guidance on dear doctor letters.
Human Drugs
AbbVies Humira Follow-on Approved for Arthritis
FDA approves AbbVies Rinvoq (upadacitinib), a 15 mg, once-daily oral Janus kinase inhibitor and follow-on therapy to its blockbuster rheumatoid arthri...
