Zongertinib PDUFA Date (Boehringer Ingelheim)
FDA PDUFA decision date for Zongertinib is August 8, 2025. Developed by Boehringer Ingelheim. Indication: NSCLC with HER2 TKD mutations. Current status: Approved.
Indication
NSCLC with HER2 TKD mutations
Regulatory details
- Company: Boehringer Ingelheim
- Therapeutic area: Oncology
- Application type: NDA
- Review type: Priority
- PDUFA date: 2025-08-08
- Outcome: Approved