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…

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…

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…

As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on regulations that could impact your business. Source: Drug Industry Daily

Among devices subject to an FDA Class I recall from 2018-2022, only one-quarter of recall notices included adequate information to accurately identify the device or component at fault, according to…

Part 1 of a two-part series on litigation trends in the medical device industry. Source: Drug Industry Daily

The EU Commission’s latest guidance on its new medical device regulations provides a detailed explanation of the required content, as well as the structure, for the summary of a report…

While not an approval pathway itself, the FDA’s Priority Review designation can put investigational drugs on a speedier track to securing an approval. Source: Drug Industry Daily

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. Source: Drug…

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. Source: Drug Industry…