Category - New Drug Applications
Lipocine Receives Complete Response Letter for TLANDO™ from U.S. FDA
FDA Grants Braeburn’s Citizen Petition Allowing Brixadi (buprenorphine) Extended-Release Injection for Opioid Use Disorder to be Available in December 2020
AVEO Oncology Announces Regulatory Update For Tivozanib In Renal Cell Carcinoma
FDA Accepts Genentech’s Biologics License Application for Satralizumab for Neuromyelitis Optica Spectrum Disorder
Horizon Therapeutics plc Announces the FDA has Granted Priority Review of the Teprotumumab Biologics License Application (BLA) for the Treatment of Active Thyroid Eye Disease (TED)
Assertio Therapeutics Provides Regulatory Update on Long-Acting Cosyntropin
Ultragenyx Announces FDA Accepts New Drug Application for UX007 (triheptanoin) for Treatment of Long-chain Fatty Acid Oxidation Disorders
Heron Therapeutics Announces FDA Acceptance of New Drug Application Resubmission for HTX-011 for Management of Postoperative Pain