PDUFA

FDA
Pharma

KalVista secures rare disease approval following FDA delay

After facing an unexpected regulatory delay last month, KalVista Pharmaceuticals has leapt into the commercial realm.
Fraiser Kansteiner Jul 7, 2025 10:14am
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Favicon Fierce Biotech

FDA 'on track' to meet all PDUFA dates, Marty Makary says

Jun 18, 2025 4:00am
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Favicon Fierce Biotech

FDA's 'heavy workload' blamed for delaying KalVista's PDUFA date

Jun 16, 2025 4:33am
FDA

FDA misses target date for GSK's Nucala in COPD

May 8, 2025 1:39pm
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FDA staff cuts threaten upcoming user fee renewal talks: Reuters

Apr 18, 2025 11:10am
Novavax

FDA misses decision deadline for Novavax COVID vaccine

Apr 3, 2025 3:28pm