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The companies argued that there was no scientific evidence available at the time of the initial labeling of the drugs to justify including such warnings. Read More
A U.S. appeals court panel has said no to resurrecting a 2019 lawsuit alleging that AbbVie broke antitrust laws by using a “patent thicket” to cover its blockbuster monoclonal antibody Humira from copycat drugs coming to market, thus exploiting the patent system. Read More
Generics makers will soon have the option to submit expedited safety reports electronically to the FDA Adverse Event Reporting System (FAERS), according to a new draft guidance that provides instructions for electronic transmission. Read More
More than 100 West Virginia cities and counties have reached a $400 million settlement with drug distributors McKesson, AmerisourceBergen and Cardinal Health, resolving allegations that the companies recklessly oversupplied West Virginia residents with opioids. Read More
Sanofi has failed to convince a federal appeals court that Viatris monopolized the market for injected epinephrine through anticompetitive pricing for its EpiPen. Read More
Swiss biotech ObsEva has announced a corporate restructuring and layoffs following a notice from the FDA that the company’s new drug application (NDA) for its lead candidate linzagolix for uterine fibroids has deficiencies that are keeping the agency from advancing its review. Read More
This second part of Drug Industry Daily’s two-part report on user fee reauthorization focuses on prospects for the Biosimilar User Fee Act and the Generic Drug User Fee Act.Read More
The agency said all changes to disposable manufacturing materials for approved drug products should be communicated to the FDA through postapproval submissions. Read More