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CDER
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 taps new CDER chief as acting CBER head after Prasad exit
Jul 30, 2025 1:10pm
Fierce Pharma
FDA taps George Tidmarsh to lead CDER
Jul 21, 2025 10:53am
Fierce Pharma
FDA's acting CDER head heads for the exit: report
Jun 23, 2025 1:48pm
Vanda sues FDA over months-long hearing delay
Apr 23, 2025 10:33am
FDA leadership 'decapitated,' former leader Janet Woodcock says
Apr 7, 2025 4:04pm