US FDA declines to approve Regeneron’s blood cancer therapy, Health News, ET HealthWorld

[Pelican Press 0]

This is the hidden content, please

• Sign In
• or
• Sign Up

US FDA declines to approve Regeneron’s blood ******* therapy, Health News, ET HealthWorld

data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///ywAAAAAAQABAAACAUwAOw==

London: The U.S. Food and ***** Administration has declined to approve Regeneron’s therapy for a common form of blood *******, the company said on Tuesday.

Regeneron was seeking regulatory approval of its therapy, linvoseltamab, in patients with multiple myeloma whose ******* has returned or worsened after at least three prior lines of treatment.

The FDA, in a so-called “complete response letter”, said the sole issue identified for approval is related to findings from a pre-approval inspection at a third-party manufacturer, the company said.

Regeneron said it is committed to working closely with the third-party manufacturer and the health regulator to bring linvoseltamab to patients, without giving any other details.

Regeneron said in early August that the FDA’s concerns about a third-party manufacturer will cause a delay in the regulatory decision for linvoseltamab, even though the issues were resolved and unrelated to the *****’s production. (Reporting by Bhanvi Satija, Sneha S K and Nilutpal Timsina in Bengaluru; Editing by Shailesh Kuber)

• Published On Aug 21, 2024 at 07:00 AM IST

Join the community of 2M+ industry professionals

Subscribe to our newsletter to get latest insights & analysis.

data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///ywAAAAAAQABAAACAUwAOw==

Download ETHealthworld App

• Get Realtime updates
• Save your favourite articles

data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///ywAAAAAAQABAAACAUwAOw==

data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///ywAAAAAAQABAAACAUwAOw==

Scan to download App
data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///ywAAAAAAQABAAACAUwAOw==

This is the hidden content, please

• Sign In
• or
• Sign Up

#FDA #declines #approve #Regenerons #blood #******* #therapy #Health #News #HealthWorld

This is the hidden content, please

• Sign In
• or
• Sign Up

This is the hidden content, please

• Sign In
• or
• Sign Up