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 reviewers raise issues with Capricor Therapeutics resubmitted deramiocel for treating cardiomyopathy in male patients with Duchenne muscular dystr...
Amgen files new scientific data and analyses in its bid to prevent FDA withdrawal of Tavneos (avacopan), arguing that the treatment continues to demon...
FDA issues a Complete Response Letter to Apiject Systems Corp., declining to approve the company's NDA for a glycopyrrolate solution drug-device combi...
FDA issues an early alert warning about a potentially high-risk issue involving certain lots of Boston Scientific's ENROUTE Transcarotid Neuroprotecti...
An FDA advisory committee 7/23 voted to recommend allowing several controversial peptides to be considered for inclusion on the agency's Section 503A ...
