1. Home
  2. Live Updates
  3. Drugs advisory committee

Live Breaking News & Updates on Drugs advisory committee

Stay informed with the latest breaking news from Drugs advisory committee on our comprehensive webpage. Get up-to-the-minute updates on local events, politics, business, entertainment, and more. Our dedicated team of journalists delivers timely and reliable news, ensuring you're always in the know. Discover firsthand accounts, expert analysis, and exclusive interviews, all in one convenient destination. Don't miss a beat — visit our webpage for real-time breaking news in Drugs advisory committee and stay connected to the pulse of your community

ODAC Decisions Confirm Benefit of Ide-Cel and Cilta-Cel in Earlier Line R/R Myeloma Therapy

Kenneth C. Anderson, MD, discusses the recent ODAC decisions for ide-cel and cilta-cel, highlighting clinical trial data supporting the indications.

United-states , America , Kennethc-anderson , Johnson , Oncologic-drugs-advisory-committee , Bristol-myers-squibb , Meeting-of-the-oncologic-drugs-advisory-committee , Drugs-advisory-committee , D , Dana-farber-cancer-institute- , Odac

Patients' Voices Largely Absent From FDA Reviews of New Cancer Drugs

The FDA encourages collection and reporting of patient-reported outcomes (PROs) in clinical trials, but a substantial proportion of applications seeking product approval lack these data. Assessment of patient-reported outcomes in clinical trials is on the rise, but they frequently are absent from requests for FDA drug approvals.

Washington , United-states , American , Gary-oderda , Peter-lurie , Oncology-drugs-advisory-committee , American-society-of-clinical-oncology , Public-health-strategy , Drug-administration , Howard-university , American-society , Clinical-oncology

Patients' Voices Largely Absent From FDA Reviews of New Cancer Drugs Patient Reported Outcomes Largely Absent From FDA Reviews of New Cancer Drugs- Renal and Urology News

The FDA encourages collection and reporting of patient-reported outcomes (PROs) in clinical trials, but a substantial proportion of applications seeking product approval lack these data. Assessment of patient-reported outcomes in clinical trials is on the rise, but they frequently are absent from requests for FDA drug approvals.

Tampa , Florida , United-states , Wisconsin , Oregon , North-carolina , Washington , Wake-forest-university , American , Peter-lurie , Gary-oderda , Edward-haksing-ip

Cilta-Cel Allows for Treatment-Free Period in Early R/R Multiple Myeloma

Saad Z. Usmani, MD, MBA, FACP, FASCO, discusses the significance of the FDA approval of cilta-cel in relapsed/refractory multiple myeloma.

New-york , United-states , Saadz-usmani , Johnson , Oncologic-drugs-advisory-committee , Janssen-biotech-inc , Meeting-of-the-oncologic-drugs-advisory-committee , Drugs-advisory-committee , Myeloma-service , Memorial-sloan-kettering-cancer-center ,

FDA's ODAC Recognizes MRD as an Accepted End Point for Accelerated Approval in Multiple Myeloma

The FDA’s ODAC voted that data support the use of minimal residual disease as an end point to support accelerated approval of treatments in multiple myeloma.

Ravia-madan , University-of-miami-sylvester-comprehensive-cancer-center , University-of-miami , National-cancer-institute , Oncologic-drugs-advisory-committee , Drugs-advisory-committee , Sylvester-comprehensive-cancer-center , Fda , Odac , Multiple-myeloma , Minimal-residual-disease

FDA adcom backs MRD as new endpoint in multiple myeloma trials

By a unanimous 12-0 vote, the U.S. FDA’s Oncologic Drugs Advisory Committee concluded that new evidence support the use of minimal residual disease (MRD) as an accelerated approval endpoint in multiple myeloma (MM) clinical trials.

Oncologic-drugs-advisory-committee , Drugs-advisory-committee , Bioworld , Multiple-myeloma , Odac , Minimal-residual-disease , Regulatory , Cancer , Us- , Fda , Endpoint

FDA Approves Cilta-Cel for Treatment of Relapsed, Refractory Multiple Myeloma

The indication is for adult patients with multiple myeloma who are refractory to lenalidomide and have previously received at least 1 line of therapy.

Binod-dhakal , Janssen-research-development , Division-of-hematology , Janssen-biotech-inc , Oncologic-drugs-advisory-committee , Johnson , College-of-wisconsin , Janssen-biotech , Postmodern-studio , Drugs-advisory-committee , Study-comparing , Versus-pomalidomide

FDA Approves Carvykti for Relapsed, Refractory Myeloma

The Food and Drug Administration approved the CAR-T cell therapy, Carvykti, for previously treated patients with multiple myeloma.

Irene-ghobrial , Binod-dhakal , Drug-administration , Dana-farber-cancer-institute , Johnson , Harvard-medical-school , Oncologic-drugs-advisory-committee , Myeloma-research-foundation , College-of-wisconsin , Division-of-hematology , Associate-professor

Johnson & Johnson's Carvykti Stands Ahead Of Bristol Myers' Rival Blood Cancer Therapy With FDA Approval For Wider Population

Friday, the FDA approved Johnson & Johnson JNJ Carvykti (ciltacabtagene autoleucel; cilta-cel) for relapsed or refractory multiple myeloma patients who have…

Oncologic-drugs-advisory-committee , Drugs-advisory-committee , News , Ggregator , Reaking-news , Uration , Edia ,

Johnson & Johnson's Carvykti Stands Ahead Of Bristol Myers' Rival Blood Cancer Therapy With FDA Approval For Wider Population - Legend Biotech (NASDAQ:LEGN), Johnson & Johnson (NYSE:JNJ)

FDA approves Johnson & Johnson's Carvykti, a BCMA-targeted therapy for relapsed or refractory multiple myeloma patients, offering hope with increased manufacturing capacity and extended collaboration efforts.

Johnson-johnsonjnj-carvykti , Tyrone-brewer , William-blair , Oncologic-drugs-advisory-committee , Johnson , Drugs-advisory-committee , Johnson-innovative , Legend-biotech , Market-perform ,