FDA grants orphan drug designation to Merck’s M7824 in biliary tract cancer

Share on facebook
Share on twitter
Share on linkedin
Share on email
Share on print

FDA has granted orphan drug designation to M7824, the first regulatory designation for the bifunctional immunotherapy, for the treatment of biliary tract cancer. The designation follows the recent presentation of the first clinical data for M7824 in BTC at the European Society of Medical Oncology congress in October.

To access this subscriber-only content please log in or subscribe.

If your institution has a site license, log in with IP-login or register for a sponsored account.*
*Not all site licenses are enrolled in sponsored accounts.

Login Subscribe

YOU MAY BE INTERESTED IN

In his first sit-down interview since beginning his role as FDA commissioner 17 days earlier, Marty Makary, a former Johns Hopkins surgeon and the only Trump pick for HHS whose confirmation received Democratic support, said he would speed up approvals for rare-disease treatments by reducing reliance on animal testing and shifting towards organoids and computational models. 

Never miss an issue!

Get alerts for our award-winning coverage in your inbox.

Login