The FDA is proposing to waive device registration fees for companies with annual revenues less than $1 million or those in bankruptcy. The move aims to alleviate financial burdens for smaller firms and those facing financial difficulties.

AstraZeneca's Tagrisso has received FDA approval for use with chemotherapy in treating advanced lung cancer with specific mutations.

Despite controversies and a failed study, Sarepta's Duchenne gene therapy, Elevidys, may soon expand its use beyond the initial age group.

The U.S. FDA recently intensified its regulatory actions by issuing warning letters for manufacturing violations and the sale of counterfeit weight loss medications online. 

The UK Competition and Markets Authority (CMA) is investigating Vifor Pharma over concerns of potential anti-competitive practices, focusing on the availability and affordability of essential anaemia treatments.

The U.S. government is set to propose drug price cuts for the pharmaceutical industry in a move already anticipated by drugmakers. This initiative is part of a broader effort to reduce healthcare costs, with the government leveraging its Medicare program to negotiate prices directly with pharmaceutical companies for certain expensive medications.

Stephen J Ubl, president and chief executive officer of the Pharmaceutical Research and Manufacturers of America (PhRMA) will join Fierce for a Fireside chat. Ubl is known as a leading health care advocate and policy expert, and represents the U.S. biopharmaceutical industry, which employs more than 800,000 Americans and invests more than $100 billion each year in R&D.