After getting fewer than 50 comments on the proposed rule, the FDA has issued its final rule on the annual report pharmaceutical companies must submit on drugs they supplied under…

A New York district judge has once again thrown out a whistleblower complaint alleging that Novartis offered doctors kickbacks to entice them to prescribe its multiple sclerosis blockbuster Gilenya (fingolimod).…

The day a bench trial was slated to begin in Delaware federal court on Gilead’s five patent disputes with generic drug makers who were poised and ready to make copies…

New generic drug approvals in 2018, 2019 and 2020 yielded $53.3 billion in savings, according to a new FDA report that analyzed results from 2,400 approved new generic drug applications.…

All people are not the same. While glaringly obvious, that truth is often ignored in clinical trials. And fixing that problem requires companies to understand and overcome a myriad of…

Planning for a drug or device recall, training for it and executing it with a heaping helping of humility are the key steps to managing a recall without sinking your…

Novartis has posted positive late-stage results for people with advanced liver cancer this week, while Amgen’s trial on a form of non-small cell lung cancer (NSCLC) caused by a genetic…

The National Institutes of Health (NIH) has begun enrolling adults and children in a phase 3 clinical trial to test the effectiveness of the smallpox antiviral TPOXX (tecovirimat) on monkeypox.…

President Biden signed an executive order Monday authorizing a new initiative to help grow U.S. biomanufacturing, curtail dependence on foreign suppliers for critical supplies like active pharmaceutical ingredients (APIs) and…

Political pressure and internet-bred conspiracy theories have eroded one of the FDA’s prime functions — the communication of scientific truth, FDA Commissioner Robert Califf said at the annual meeting of…