PDUFA

AZ
Favicon Fierce Biotech

FDA delays ruling on AstraZeneca drug after negative adcomm vote

The FDA deferred its ruling on AstraZeneca’s camizestrant to review analyses filed after an advisory committee voted against the breast cancer asset.
Nick Paul Taylor May 27, 2026 4:43am
Epkinly

Genmab touts new data that set up Epkinly for FL expansion

Aug 8, 2025 7:25am
FDA

KalVista secures rare disease approval following FDA delay

Jul 7, 2025 10:14am
Clock in front of the subway
Favicon Fierce Biotech

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

Jun 18, 2025 4:00am
FDA stop sign
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