FDA OKs Belzutifan for Cancers Tied to von Hippel-Lindau Disease medscape.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from medscape.com Daily Mail and Mail on Sunday newspapers.
Penpulimab Monoclonal Antibody (PD-1) Obtains Marketing Approval in China prnewswire.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from prnewswire.com Daily Mail and Mail on Sunday newspapers.
Kadmon Announces REZUROCK(TM) (belumosudil) Added to National Comprehensive Cancer Network(R) Clinical Practice Guidelines in Oncology for Hematopoietic Cell Transplantation
ACCESSWIRE
05 Aug 2021, 06:05 GMT+10
NEW YORK, NY / ACCESSWIRE / August 4, 2021 / Kadmon Holdings, Inc. (Nasdaq:KDMN) today announced that the National Comprehensive Cancer Network
® (NCCN) added REZUROCK
TM (belumosudil) tablets to its NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines
®) for Hematopoietic Cell Transplantation (HCT) in the Pre-Transplant Recipient Evaluation and Management of Graft-Versus-Host Disease (GVHD). The NCCN Guidelines in the United States now include REZUROCK with a Category 2A designation as a suggested systemic agent for steroid-refractory chronic GVHD. The rapid inclusion of REZUROCK into the NCCN guidelines shortly after full FDA approval validates the potential clinical impact of REZUROCK in this difficult-to-treat therapeutic landscape, said Harlan W. Waks
These Are The Top Priorities & Challenges For New CDER Director Patrizia Cavazzoni, M.D.
By Lowell M. Zeta and Lynn Mehler, Hogan Lovells
Scientific breakthroughs have revolutionized the development of new and more personalized therapies to address unmet medical needs through enhanced technologies and data-informed capabilities. Advances in data infrastructure, clinical trial design, and other medical product technologies and the 21st Century Cures Act and other legislation aim to bring new innovations to patients who need them faster. These developments are requiring the FDA to rethink the ways it applies and interprets the law and to speed up its efforts to adopt innovative scientific approaches to inform regulatory decisions that make products more effective, safer, and available sooner.