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KEYTRUDA QLEX

BLA · Biologics License Application · Sponsor: MERCK SHARP DOHME · Approved 2025-09-19

Drug application

FDA Application #
BLA761467
Application type
Biologics License Application
Brand name
KEYTRUDA QLEX
Generic name
PEMBROLIZUMAB AND BERAHYALURONIDASE ALFA-PMPH
Active ingredients
PEMBROLIZUMAB; BERAHYALURONIDASE ALFA-PMPH
Dosage form
INJECTABLE
Route
INJECTION
Marketing status
Prescription
Sponsor
MERCK SHARP DOHME
Manufacturer
Merck Sharp & Dohme LLC
First approval
2025-09-19

Source

Authoritative
Drugs@FDA application overview
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