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Two draft guidances released by the FDA on Wednesday aim to reduce lag time between approval of a drug for adult use and its subsequent pediatric approval by clarifying requirements and processes for pediatric drug development. Read More
Clinical trial sites venturing into the growing field of digital therapeutics (DTx) need the appropriate infrastructure — as well as tech know-how and adaptability — while sponsors need to be willing to offer training and support, iron out hurdles that come with remote components and simplify these trials whenever possible, a clinical research expert advises. Read More
Upcoming events in the coming weeks include six FDA advisory committee meetings as well as webinars and conferences on subjects ranging from IVDs and LDTs, developing SOPs and pharmaceutical quality risk management. 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
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