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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
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
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
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
The rising obesity rate in the U.S. could foil Perrigo’s bid to offer the U.S.’s first OTC oral contraceptive, according to FDA briefing documents in advance of a two-day advisory committee meeting this week. Read More
Despite more than half of treated patients developing adverse reactions, Eli Lilly will seek a traditional full approval for donanemab after topline phase 3 data showed that the antiamyloid antibody prevented further cognitive decline in 47 percent of early-stage Alzheimer’s patients and slowed decline by up to 36 percent on two other scales. Read More
GSK has crossed the finish line with Arexvy (RSVPreF3-AS01E), the first respiratory syncytial virus (RSV) vaccine to win FDA approval for individuals age 60 years and older, but approval of Pfizer’s RSV candidate, Abrysvo (RSVpreF), may not be far behind. Read More
After heated delays involving a competitor and the FDA, Dublin-based Avadel Pharmaceuticals has won FDA approval for Lumryz, its extended-release formulation of sodium oxybate for the treatment of cataplexy or excessive daytime sleepiness in adults with narcolepsy. Read More