UroGen Announces FDA Acceptance of its New Drug Application for UGN-102
5 days ago · UGN-102 could become the first FDA-approved medicine for the treatment of low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The FDA has assigned a Prescription Drug ...
FDA accepts new drug application for UGN-102 in NMIBC
5 days ago · The Prescription Drug User Fee Act (PDUFA) target action date is June 13, 2025. "The FDA acceptance of our NDA is a pivotal moment in our journey to bring UGN-102 to patients,” said Liz Barrett, President and Chief Executive Officer of UroGen, in the news release. 1 “UGN-102 could be the first FDA-approved medicine for LG-IR-NMIBC, offering a novel approach that could expand treatment ...
UroGen Announces FDA Acceptance of its New Drug Application for UGN-102
5 days ago · PDUFA goal date set for June 13, 2025 UGN-102 would be the first FDA-approved medicine for LG-IR-NMIBC, if approved "The FDA acceptance of our NDA is a pivotal moment in our journey to bring UGN ...
UroGen Announces FDA Acceptance of its New Drug Application for UGN-102
5 days ago · PRINCETON, N.J., October 15, 2024--UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers ...
FDA Accepts New Drug Application for UGN-102 in Bladder Cancer
3 days ago · A new drug application (NDA) has been accepted by the Food and Drug Administration (FDA) for the intravesical solution of UGN-102 (mitomycin) in the treatment of low-grade intermediate-risk non-muscle-invasive bladder cancer, positioning UGN-102 to potentially become the first FDA-approved agent for this patient population, according to a press release from UroGen Pharma, the drug’s ...
FDA accepts UroGen’s UGN-102 NDA for bladder cancer treatment
5 days ago · The Phase III multinational, single-arm, multicentre ENVISION study, met its primary endpoint with a 79.6% complete response rate three months after the first UGN-102 instillation. Further results from the study showcased an 82.3% 12-month duration of response as determined by the Kaplan-Meier estimate in subjects with complete response (CR) at ...
FDA Accepts New Drug Application for UGN-102 for Bladder Cancer
5 days ago · The FDA has accepted a New Drug Application for UGN-102 (mitomycin) in treating patients with low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC), according to a news release from the drug’s developer, UroGen Pharma. 1
UGN-102, in Development as the Potential First Non-Surgical …
Jul 27, 2023 · UGN-102, a non-surgical therapy for low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC), met primary endpoints in both ATLAS and ENVISION trials. The company will host a webinar on July 27, 2023 to …
NDA submitted to FDA for UGN-102 in low-grade intermediate …
Aug 14, 2024 · UroGen Pharma has completed submission of a new drug application (NDA) seeking FDA approval of the investigational drug UGN-102 (mitomycin) for intravesical solution for the treatment of patients with low-grade (LG) intermediate-risk (IR) non–muscle-invasive bladder cancer (NMIBC), the company announced in a news release. 1
UroGen Announces Results from ATLAS Showing Robust UGN-102 …
May 4, 2024 · Utilizing UroGen’s proprietary RTGel ® technology, a sustained release, hydrogel-based formulation, UGN-102 is designed to enable longer exposure of bladder tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means. UGN-102 is delivered to patients using a standard urinary catheter in an outpatient setting.
- Some results have been removed