News

BioSpace1d
Roche’s Genentech Fails to Win Adcomm Backing for Columvi Expansion
The ODAC cited concerns with patient populations in clinical trials used to support the proposed expansion. Johnson & Johnson ...
Applied Clinical Trials Online1d
FDA Panel Votes Against Columvi-GemOx sBLA for R/R DLBCL Over Regional Data Concerns from STARGLO Trial
The FDA’s Oncologic Drugs Advisory Committee voted against an application for Columvi (glofitamab) plus GemOx for ...
Roche provides update on FDA Advisory Committee meeting on Columvi combination for people with relapsed or refractory diffuse large B-cell lymphoma
Columvi is the first bispecific antibody to show a statistically significant and clinically meaningful 41% survival benefit ...
Pharmabiz20h
Roche provides update on US FDA Advisory Committee meeting on Columvi combination for people with relapsed or refractory DLBCL
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 ...
Genentech's Columvi label expansion gets negative vote by FDA committee
Genentech, a Roche Group company (OTCQX:RHHBY) (OTCQX:RHHBF), said on Tuesday that a U.S. FDA advisory committee voted ...
CURE1d
FDA’s ODAC Casts Votes on the Use of Certain Treatment Options in Cancer Care
The FDA'S ODAC has casted their votes on the use of certain treatments in both the relapsed/refractory DLBCL and myeloma ...
Endpoints News2d
FDA ad­comm votes against new in­di­ca­tion for Genen­tech's can­cer drug
The FDA's Oncologic Drugs Advisory Committee voted 8 to 1 against whether Genentech's pivotal trial is applicable to the US ...
Fierce Pharma2d
FDA leaders push for more US enrollment in cancer trials
What's more, both FDA Commissioner Martin Makary, M.D., and longtime FDA oncology chief Richard Pazdur, M.D., have a new ...
Medical Dialogues1d
USFDA Advisory Committee reviews Roche Columvi Combo for diffuse large B-cell Lymphoma
Basel: Roche has announced that a US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) discussed ...
Fierce Pharma14d
In first oncology expert meeting under Makary, FDA spotlights cancer drugs from J&J, Pfizer, Roche and UroGen
The FDA’s Oncologic Drugs Advisory Committee (ODAC) is planning to host its first meeting under new agency commissioner Marty ...
Health Care Roundup: Market Talk
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 ...