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 ...

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

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

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

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

The latest Market Talks covering the Health Care sector. Published exclusively on Dow Jones Newswires at 4:20 ET, 12:20 ET and 16:50 ET.0434 ET – Samsung Biologics is expected to sustain solid ...

Genentech, a Roche Group company (OTCQX:RHHBY) (OTCQX:RHHBF), said on Tuesday that a U.S. FDA advisory committee voted ...

The FDA's Oncologic Drugs Advisory Committee voted 8 to 1 against whether Genentech's pivotal trial is applicable to the US ...

The FDA’s Oncologic Drugs Advisory Committee (ODAC) is planning to host its first meeting under new agency commissioner Marty ...

Approval based on Phase III STARGLO study where Columvi in combination with chemotherapy showed a 41% reduction in the risk of death compared to MabThera/Rituxan plus chemotherapy1,2 DLBCL is an ...