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…

Netherlands-based devicemaker Philips has agreed to pay $62 million to settle charges made by the U.S. Securities and Exchange Commission (SEC) that it “engaged in improper conduct to influence foreign…

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…