Over the past week, the FDA issued several documents, including a final guidance for testing drug components for diethylene glycol and ethylene glycol and the announcement of a discussion paper…

An FDA advisory committee voted in favor of ARS Pharmaceuticals’ neffy (ARS-1), an intranasal epinephrine spray, as an alternate to epinephrine injection for severe anaphylactic allergic reactions despite the absence…

Four bills aimed at encouraging drug development and controlling costs survived markup by the Senate Health, Education, Labor and Pensions (HELP) Committee on Thursday, lining them up for consideration and…

The FDA’s approval of Otsuka Pharmaceutical’s Rexulti (brexpiprazole) to treat agitation in people with Alzheimer’s disease (AD) makes it the first drug approved for this indication, reported in approximately half…

A U.S. District Court in Illinois has ordered Eli Lilly to pay triple damages — $183.7 million — for violating the False Claims Act by underpaying rebates to Medicaid. Source:…

This month has started strong with the May 11 approval of Rexulti to treat agitation in Alzheimer’s dementia, the only drug approved to treat this common Alzheimer’s symptom. Source: Drug…

Senators from both sides of the aisle pressed insulin makers and pharmacy benefit managers (PBM) on the drug’s high cost during a committee hearing Wednesday, where the two groups accused…

Despite the FDA’s lingering concerns over study data, a 17-member advisory committee unanimously supported Perrigo’s bid to switch its progestin-only oral contraceptive Opill (norgestrel 0.075 mg) from prescription to OTC.…

Gilead Sciences has prevailed in what appears to be the first lawsuit filed by the U.S. government against a drugmaker in an attempt to enforce patent rights, dodging an almost…

Multiple unaddressed violations of current good manufacturing practice, FDA regulations and noncompliance with a 2012 consent decree have earned India’s Sun Pharmaceutical a hefty list of corrective actions to complete…