FdaApplication
BLA 761467
Identifiers
- fda_app_no: BLA761467
Properties
| Property | Value |
|---|---|
| applicant_name | Merck Sharp & Dohme LLC |
| application_type | BLA |
| approval_date | 2025-09-19 |
Revenue by product
KEYTRUDA QLEX
| Period | Revenue |
|---|---|
| Q2 2026 | $463.0M |
| Q1 2026 | $128.0M |
| Q2 2025 | $0.0M |
| Q1 2025 | $0.0M |
Revenue as this company reported it for this product. A combination product's amount is stated once, for the product, and never divided across its ingredients.
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| KEYTRUDA QLEX | PEMBROLIZUMAB; BERAHYALURONIDASE ALFA-PMPH | 395MG/2.4ML; 4,800UNITS/2.4ML (165MG/2,000UNITS/ML) | Injection |
| KEYTRUDA QLEX | PEMBROLIZUMAB; BERAHYALURONIDASE ALFA-PMPH | 790MG/4.8ML; 9,600UNITS/4.8ML (165MG/2,000UNITS/ML) | Injection |
2 products