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.
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
The Securities and Exchange Commission (SEC) announced Monday that Quanta and two of its top executives have agreed to settle fraud charges brought against the company, stemming from statements the company made related to a proposed COVID-19 treatment in 2021. Read More
The FTC announced Tuesday that it is suing to block Amgen from its intended $27.8 billion acquisition of Horizon Therapeutics, claiming the buy would create a monopoly on drugs used to treat two serious illnesses. Read More
As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on regulations that could impact your business. 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
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