PDUFA

Anatomical model of human arm and torso showing muscle
Pharma

Scholar Rock scores its first FDA approval for SMA treatment

The treatment, which is set to “ship in the coming days” is projected to cost $310,000 annually.
Donavyn Coffey Sep 14, 2026 10:37am
AZ
Favicon Fierce Biotech

FDA delays ruling on AstraZeneca drug after negative adcomm vote

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