We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Milestone Pharmaceuticals’ investigational nasal spray etripamil claimed a phase 3 win, with topline data indicating that abnormal heart rhythms normalized in 64 percent of patients with paroxysmal supraventricular tachycardia (PSVT) compared to 31 percent who used a placebo spray. Read More
In a trio of guidances released Monday, the FDA laid out new recommendations for research on cancer drugs, including how to develop drugs for acute myeloid leukemia (AML), how to classify the side effects of immunotherapies and best practices for developing therapies targeting biomarkers across multiple cancer types. Read More
A failure to withdraw marketing approval of Covis’ preterm birth drug Makena would amount to a failure of FDA’s Accelerated Approval pathway, according to Peter Stein, director of the agency’s Office of New Drugs. Read More
The FDA rapped Fresenius Kabi for batch discrepancies and contamination issues, among other quality lapses, following an inspection of its Melrose Park, Ill., facility. Read More