The FDA’s Oncologic Drugs Advisory Committee voted against an application for Columvi (glofitamab) plus GemOx for ...

Columvi is the first bispecific antibody to show a statistically significant and clinically meaningful 41% survival benefit ...

Columvi combo for relapsed diffuse large B-cell lymphoma faces approval hurdle. Discover implications for U.S. Read more here ...

What's more, both FDA Commissioner Martin Makary, M.D., and longtime FDA oncology chief Richard Pazdur, M.D., have a new ...

The ODAC cited concerns with patient populations in clinical trials used to support the proposed expansion. Johnson & Johnson ...

Roche provides update on US FDA Advisory Committee meeting on Columvi combination for people with relapsed or refractory DLBCL: Basel Thursday, May 22, 2025, 12:00 Hrs [IST] Roche ...

Basel: Roche has announced that a US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) discussed ...

For J&J, there was a positive outcome as the Oncologic Drugs Advisory Committee (ODAC) voted six to two in favour of approval ...

The FDA'S ODAC has casted their votes on the use of certain treatments in both the relapsed/refractory DLBCL and myeloma ...

In a somber end to an FDA advisory committee’s two-day scouring of multiple drugmakers’ oncology data, Pfizer’s pitch to ...

The FDA is likely to approve the first treatment for smoldering multiple myeloma but pass on a new option relapsed/refractory DLBCL, after votes by its Oncologic Drugs Advisory Committee.

As reported late last year, the AQUILA trial showed that treatment with daratumumab reduced the risk of progression to ...