Submission of a Rolling NDA to the FDA for UGN-102 initiated
“The submission of the CMC portion of the NDA for UGN-102 marks a significant milestone for UroGen and underscores our dedication to advancing innovative therapies for the benefit of individuals grappling with low-grade, intermediate-risk non-muscle invasive bladder cancer,” said Liz Barrett, President and CEO, UroGen. “We look forward to working closely with the FDA throughout the review process and remain steadfast in our commitment to address unmet medical needs in the uro-oncology space and advance patient care.”
Share:
More News
“This positive opinion from the CHMP highlights the significant unmet need and importance of effective treatment options for adult r/r B-ALL,” said Dr. Christian Itin, Chief Executive Officer of Autolus. “With FDA approval received in November 2024 and an MHRA conditional marketing authorization received in April 2025, we are on
“While we are disappointed by today’s outcome, we continue to believe our clinical data support UGN-102 for the treatment of recurrent LG-IR-NMIBC, a disease with no FDA-approved therapies,” said Liz Barrett, President and CEO of UroGen. “The FDA carefully considers the independent advice from ODAC, and we look forward to
“Columvi in combination with GemOx demonstrated a 41% reduction in risk of death in a Phase III, randomized, multiregional clinical trial, supporting its recent approval by the European Commission and inclusion in the U.S. National Comprehensive Cancer Network treatment guidelines as a category 1 preferred regimen,” said Levi Garraway, M.D.,
Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare, said, “Today’s approval marks another important milestone for InnoCare as we will celebrate our 10th anniversary this year. I would like to extend my sincere gratitude to all the physicians, patients, partners and employees who have contributed to this achievement. DLBCL
