← FDA DRUG APPROVALS

FDA BLA · BLA761134

RYZNEUTA

efbemalenograstim alfa-vuxw

Sponsor: EVIVE BIOTECHNOLOGY

APPLICATION
BLA761134
TYPE
BLA
ORIGINAL APPROVAL
2023-11-16
LATEST ACTION
2023-11-16
ROUTE
SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

RYZNEUTAPrescription
EFBEMALENOGRASTIM ALFA-VUXW 20MG/ML · INJECTABLE · INJECTION

Approval history

2023-11-16Type 1 - New Molecular Entity · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Biologics industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →