Category - New Drug Applications
UroGen Submits Completed UGN-102 NDA Seeking Approval as the First FDA-Approved Treatment for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer
FDA Accepts LEO Pharma’s Filing of Delgocitinib Cream New Drug Application for the Treatment of Chronic Hand Eczema
Iterum Therapeutics Provides Update on FDA Advisory Committee Discussion of Oral Sulopenem for the Treatment of uUTI in Adult Women
AbbVie Submits Biologics License Application to the FDA for Telisotuzumab Vedotin (Teliso-V) in Previously Treated Non-Small Cell Lung Cancer
PTC Therapeutics Announces FDA Acceptance for Filing of NDA for Sepiapterin for the Treatment of Pediatric and Adult Phenylketonuria Patients
Stealth BioTherapeutics Announces Positive Vote from FDA Advisory Committee Meeting Supporting Potential Approval of Elamipretide for the Treatment of Barth Syndrome
U.S. Food and Drug Administration (FDA) Accepts New Drug Application for Elinzanetant
UroGen Announces FDA Acceptance of its New Drug Application for UGN-102