FDA reviewers raise issues with Capricor Therapeutics resubmitted deramiocel for treating cardiomyopathy in male patients with Duchenne muscular dystr...
Novo Nordisk intensifies pressure against Eli Lilly under a motion seeking a preliminary injunction to stop Eli Lilly's misleading GLP-1 advertising c...
CBER recently used a virtual town hall to urge developers of cell and gene therapies to take advantage of early engagements with the agency well befor...
An FDA final guidance encourages sponsors of oncology clinical trials to broaden eligibility criteria by including more patients with reduced performa...
FDA encourages cancer clinical trial sponsors to adopt more flexible eligibility criteria related to washout periods and concomitant medications.
A final FDA guidance urges sponsors of cancer clinical trials to broaden laboratory value-based eligibility criteria to reduce unnecessary barriers to...
FDA announces an 8/6 educational Webinar to provide stakeholders with additional information about its proposed Expedited Investigational New Drug Pil...
Amgen files new scientific data and analyses in its bid to prevent FDA withdrawal of Tavneos (avacopan), arguing that the treatment continues to demon...
