NDA submitted to U.S. FDA for Vepdegestrant for Patients with ESR1-Mutated ER+/HER2- Advanced or Metastatic Breast Cancer
“This milestone comes after an exciting presentation at the American Society of Clinical Oncology’s annual meeting,” said John Houston, Ph.D., Chairperson, Chief Executive Officer and President at Arvinas. “We look forward to the NDA review and to the first ever FDA-approved PROTAC ER degrader potentially being available to patients who could benefit from a much needed, new treatment option.”
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“Patients with non-muscle invasive bladder cancer continue to face a significant risk of disease recurrence despite available treatment options,” said Mark Schoenberg, M.D., Chief Medical Officer of UroGen. “UGN-501 is an investigational next-generation oncolytic virus designed to selectively destroy tumor cells while generating an anti-tumor immune response. FDA clearance of
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