← FDA Drug Approvals (Drugs@FDA)

LYNOZYFIC

BLA · Biologics License Application · Sponsor: RENGENERON PHARMACEUTICALS, INC. · Approved 2025-07-02

Drug application

FDA Application #

BLA761400

Application type

Biologics License Application

Brand name

LYNOZYFIC

Generic name

LINVOSELTAMAB-GCPT

Active ingredients

LINVOSELTAMAB-GCPT

Dosage form

SOLUTION

Route

INJECTION

Marketing status

Prescription

Sponsor

RENGENERON PHARMACEUTICALS, INC.

Manufacturer

Regeneron Pharmaceuticals, Inc.

First approval

2025-07-02

Source

Authoritative

Drugs@FDA application overview

Machine

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