FDA regulatory calendar

PDUFA Calendar

Track FDA action dates and advisory committee meetings by month. Each event links to its company, drug, indication and source-backed research record.

115PDUFA and ADCOM events tracked

Monthly view

January 2027

SunMonTueWedThuFriSat1 2 3 4PDUFA · NUVB 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19

FDA regulatory calendar

January 4, 2027

1 regulatory events

04Jan 2027

NUVBPDUFA

IBTROZI (Taletrectinib) (ROS1 inhibitor)

TKI-naïve and TKI-pretreated advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC)

Approval decision

Event details Source

Pro

PDUFA dates and FDA advisory meetings

Use the monthly FDA calendar to review PDUFA target dates and advisory committee meetings, then open each event for drug, company, indication and source context.