PDUFA

Epkinly
Pharma

Genmab touts new data that set up Epkinly for FL expansion

Genmab and AbbVie have presented new data that could help grow the reach of their blood cancer drug Epkinly in follicular lymphoma.
Kevin Dunleavy 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
red tape regulators FTC FDA business goal regulatory

FDA staff cuts threaten upcoming user fee renewal talks: Reuters

Apr 18, 2025 11:10am