Pf-08634404, Enfortumab Vedotin, Padcev
Urothelial Cancer, Urothelial Carcinoma, Advanced/Metastatic Urothelial Cancer
Phase I/II
Recruiting
Symbiotic-GU-06: A Study to Learn About PF-08634404 Alone or In Combination With Enfortumab Vedotin in Urothelial Cancer
Feb 12, 2026
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Pudexacianinium Chloride
Sentinel Lymph Node Biopsy, Melanoma, Breast Cancer
Phase II
Terminated
A Study to Find the Best Dose of ASP5354 to Show Lymph Nodes in People With Breast Cancer or Melanoma During Surgery
Jul 11, 2022
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Astellas Pharma Inc (YPH) have in its pipeline
YPH is currently developing the following drugs: Pf-08634404, Enfortumab Vedotin, Padcev, Sham Surgery, Asp2246, Brain Surgery, Rehabilitation Therapy, Panitumumab, Asp5834. These drug candidates are in various stages of clinical development as the company works toward FDA approval.