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. Source: Drug Industry Daily

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…

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…

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…

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…

OptumHealth Care Solutions has recalled its Nimbus II Plus infusion pumps — a recall now deemed Class I by the FDA — because of the potential for the device to…

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…

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. Source: Drug Industry Daily

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,…

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…