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.
Adding to the already numerous lawsuits, the Teamsters union sued opioid manufacturers, distributors and pharmacy benefit managers in the U.S. District Court for the Northern District of Ohio over their alleged role in the addiction crisis. Read More
The Senate Committee on Health, Education, Labor and Pensions unanimously advanced the Opioid Crisis Response Act (S. 2680) Tuesday but voted down an amendment to impose tough penalties on drugmakers. Read More
Generic drug approvals were in the spotlight during remarks by FDA Commissioner Scott Gottlieb before a Senate appropriations subcommittee on the FDA’s fiscal year 2019 budget request. Read More
The FDA sent Pfizer a complete response letter for its proposed biosimilar of Genentech’s Herceptin (trastuzumab), saying it needs to see more data before approving the breast cancer drug. Read More
The FDA’s Center for Biologics Evaluation and Research published guidance on information to include in biologics license application datasets, including data on clinical trial endpoints and adverse events. Read More
An FDA advisory committee was split on Monday over several questions on Eli Lilly’s rheumatoid arthritis dosage, voting in favor of efficacy for both a 2 mg and 4 mg dosage but voting against the safety and risk-benefit profile of the larger dosage. Read More