Invivyd’s VYD2311 Phase III Study Meets Safety Goals, Eyes FDA Accelerated Approval

Invivyd (NASDAQ:IVVD) reported topline results from its Phase III LIBERTY study of VYD2311, an investigational low-dose intramuscular monoclonal antibody designed to prevent COVID-19, and outlined ...
irblog.prnewswire.com

Accelerated Cure Project & iConquerMS to Launch the Largest-Ever Study of a Novel Therapy to Treat Fatigue in Multiple Sclerosis

WALTHAM, Mass., May 29, 2024 /PRNewswire/ -- The iConquerMS™ People-Powered Research Network (PPRN) (www.iConquerMS.org), a research initiative of the Accelerated Cure Project (ACP), is partnering ...

Invivyd outlines accelerated approval submission path with FDA for COVID-19 antibody

Invivyd Inc. IVVD on Tuesday announced topline results from its Phase 3 LIBERTY study of its investigational COVID-19 ...
Healio

Confirmatory study delay after FDA accelerated approval should be ‘cautionary sign’

Please provide your email address to receive an email when new articles are posted on . Cancer drugs that received accelerated approval gained regular approval faster when their confirmatory trials ...

A study of 52,198 people linked certain conditions to faster brain aging. ADHD wasn’t one of them

Researchers analyzed thousands of brain scans to see how different conditions influenced someone’s predictive age difference.
pharmaphorum

Study points to weaknesses in FDA accelerated approval path

Less than half of the cancer therapies that were granted accelerated approval by the FDA between 2013 and 2017 showed a clinical benefit in a confirmatory trial within the next five years. That is the ...