Mesoblast Sees Accelerated Path To Market For Revascor In Sickest Heart Failure Patients
Executive Summary
US FDA agrees to plan to seek approval for ‘off the shelf’ cell therapy with Phase II data showing fewer major mucosal bleeding events in end-stage heart failure patients implanted with mechanical assist devices; confirmatory Phase III is set to begin this year.
You may also be interested in...
Change Is Constant For Pneumococcal Vaccines: US CDC Prepares For Merck’s V116
As Merck’s 21-valent vaccine approaches its 17 June user fee goal, the US CDC’s vaccine committee is looking at new adult age-based recommendations and bracing for a full pipeline led by GSK’s 24-valent candidate.
US FDA Expects Joint AdComm Briefing Document, Oncology Chief Says
The combined format is the new default for briefing advisory committee members, US FDA Oncology Center of Excellence Director Pazdur declared.
Minimal Residual Disease Gains Max US FDA AdComm Support For Myeloma Trials
The US FDA’s Oncologic Drugs Advisory Committee unanimously agreed that accelerated approvals should be enabled by multiple myeloma trials using MRD as a surrogate endpoint.