In some cases, drugmakers have accused the FDA of reversing course on earlier feedback. Based on engagements with the agency, ...
The therapy shrunk tumors in 46 percent of patients in a Phase I trial and showed strong PSA responses at the recommended dose.
The FDA said it could not agree to an approval path for AMT-130 based on Phase I/II data and recommended UniQure run a randomized, controlled study.
The firm has four clinical-stage pipeline candidates using its conditionally active biologic antibody technology.
The agency and the firm have agreed on certain risk mitigation measures for the MAGNITUDE and MAGNITUDE-2 trials of nexiguran ziclumeran.
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