RecallHawk

Summary

FDA approved Unknown by MERCK SHARP AND DOHME LLC. BLA (Biologic) approval (Type 9 - New indication submitted as distinct BLA, consolidated) on 2025-10-15.

Details

Source

Drug Approval

External ID

BLA761495-1

Action Date

2025-10-15

Status

Approved

Category

drug

Product Code

BLA (Biologic)

Product Description

Unknown. Application: BLA761495

Context & Analysis

Frequently Asked Questions

How often does MERCK SHARP AND DOHME LLC have FDA actions?

This is the only FDA action we have on record for MERCK SHARP AND DOHME LLC in our database.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "BLA761495-1" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

Want to know the moment something like this happens?

Get alerts for drug

Related Actions