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Peter Marks
Biotech
FDA proposes new approval pathway for rare diseases
To be eligible for the process, the investigational drug must take aim at correcting or replacing the specific genetic defect underlying the disease.
Gabrielle Masson
Sep 3, 2025 1:20pm
Fierce Pharma
FDA's acting CDER head heads for the exit: report
Jun 23, 2025 1:48pm
FDA leadership 'decapitated,' former leader Janet Woodcock says
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FDA's new platform guidance aims to smooth regulatory encounters
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How Peter Marks plans to prevent '3 billion visits' to FDA
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Peter Marks says FDA ready to review novel cancer vaccines
Apr 3, 2024 2:39pm