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Despite lingering concerns of a potential relationship to preterm birth (PTB), an FDA advisory committee supported Pfizer’s maternal respiratory syncytial virus vaccine Abrysvo (RSVpreF) to prevent severe RSV in infants by a vote of 10-4. Read More
In a briefing document for an advisory committee meeting this week, the FDA signaled support for Pfizer’s respiratory syncytial virus (RSV) vaccine Abrysvo (RSVpreF), which has shown to reduce risk of severe infection by 81 percent in infants whose mothers received it while pregnant. Read More
While not an approval pathway itself, the FDA’s Priority Review designation can put investigational drugs on a speedier track to securing an approval. Read More
On a split 8-6 vote, an FDA advisory committee supported an Accelerated Approval for Sarepta’s SRP-9001, a first-in-class gene therapy for Duchenne muscular dystrophy, which strikes young boys. Read More
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
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