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)…
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…
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…
The U.S. Department of Justice (DOJ) announced that three members of a Miami-based research center have been charged for allegedly running a years-long scheme to falsify clinical trial data for…
The Department of Health and Human Services (HHS) will have to come up with a plan to force down the cost of prescription drugs under an executive order signed by…
In the wake of the reauthorization of the Generic Drug User Fee Amendments (GDUFA), the FDA has updated its guidance for prior approval supplements (PAS) and amendments for abbreviated new…
The FDA rapped Fresenius Kabi for batch discrepancies and contamination issues, among other quality lapses, following an inspection of its Melrose Park, Ill., facility. Source: Drug Industry Daily
After years of legal wrangling, the FDA is still grappling with the issue of how exactly to define “exclusivity” in its orphan drug program, according to one senior agency official…
GSK has unveiled impressive numbers for its respiratory syncytial virus (RSV) vaccine, touting an overall efficacy rate of more than 94 percent against severe disease in people age 60 years…
Companies submitting or holding drug applications who plan to implement a chemistry, manufacturing, and controls (CMC) postapproval change may gain faster agency reviews using a comparability protocol (CP), according to…