The FDA database lists a supplement dated 25 September 2026 to application BLA 761216 for adalimumab-aqvh (entry title Yusimry), held by Emerge Bioscience. The record names the product and the applicant. It does not say what the supplement changed, such as labelling, manufacturing or indications.
A supplement to an existing application is a post-approval change. Without the detail it should not be read as a new indication or a safety communication.
Check the current FDA label before relying on any change. Availability in India and CDSCO status for this product are not stated in the source.
- The FDA lists a supplement to BLA 761216 for adalimumab-aqvh, dated 25 September 2026.
- The entry does not say what changed.
- It should not be read as a new indication or safety warning.
- Check the current FDA label before relying on any change.
- CDSCO status is not stated in the source.
Why it matters
Supplement entries are easy to over-read, and this one carries no stated clinical change.
Don't overread it
A licence supplement is not a new indication.
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