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.
Astellas Pharma has received FDA approval of its Veozah, the first nonhormonal treatment for moderate-to-severe vasomotor symptoms (VMS) of menopause — primarily hot flashes and night sweats. Read More
The FDA is seeking feedback on a discussion paper focused on using AI and machine learning (ML) in drug development as well as in the development of medical devices intended to be used with drugs. Read More
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 on AI. Read More
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 of clinical data. Read More
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 vote by the full chamber. Read More
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 of people with AD. Read More
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. Read More
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. Read More
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 each other of driving up costs and lawmakers often appeared baffled by the opaque schemes of drug pricing. Read More
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. Read More