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...
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...
