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.
Novartis has taken up the legal sword against Maryland and West Virginia over state legislation that would widen the powers of the controversial 340B program. Read More
More than 70,000 Zantac cases may go to trial following Delaware Superior Court Judge Vivian Medinilla’s order allowing plaintiffs’ expert witnesses to testify in court that the drug may cause cancer. Read More
In responding to an FTC/HHS request for information (RFI) on how drug wholesalers and group purchasing organizations (GPOs) influence generic drug shortages, the trade group for generic and biosimilar drug manufacturers has requested an investigation of the drug buyers’ practices. Read More
How can regulators judge the efficacy and safety of a product that makes patients feel so good, so quickly, that trial blinding is impossible, and the drug’s positive effects may carry abuse potential? Read More
As the second session of the 118th Congress begins, FDAnews will track important pending legislation, that has been acted on since Oct. 1, 2023 to keep you updated on laws and regulations that could impact your business. Read More
This edition of Quick Notes focuses on FDA drug approvals for relapsed or refractory lymphoma, a nighttime non stimulant liquid ADHD treatment for children, extensive-stage non-small cell lung cancer and an mRNA vaccine for RSV. Read More
Bkemv, like Soliris, has a boxed warning that states that eculizumab products increase the risk of serious and life-threatening meningococcal infections. Read More
Novo Nordisk has sued nine more companies for selling products billed as containing semaglutide, a primary ingredient in the Danish pharma’s popular weight loss drug Wegovy. Read More
Sanofi and development partner Regeneron are riding a regulatory roller coaster, with the EU giving Dupixent (duplilumab) a nod for chronic obstructive pulmonary disease (COPD) even as the FDA hedges, asking for more phase 3 data before granting the new indication. Read More
This month a dextromethorphan-based medicine flunked out for AD agitation, but agents for schizophrenia, mantle cell lymphoma and a clotting disorder did well, with some ready to make the regulatory leap. Read More
This week, the FDA issued a final rules related to the administrative destruction of medical devices that are thought to be counterfeit and announcing the termination of the Science Advisory Board to the National Center for Toxicological Research. Draft guidance was published on the platform technology designation program for drug development. Read More