Decision to require labeling for Zarxio that is identical to its reference product cannot be squared with agency's representation in the Vascepa off-label promotion lawsuit that failure to expressly disclose when studies were conducted using other products is misleading, petition says.
FDA statements in recent litigation with Amarin Corp. PLC involving off-label promotion undercut the agency's decision to apply a generic-like labeling approach to the first biosimilar approval, AbbVie Inc. says.
The agency's view that it would be misleading for Amarin not to disclose whether certain studies that it sought to provide to doctors did or did not involve Vascepa (icosapent...
Webpages, a healthcare professional pamphlet and a medical conference exhibit booth panel make unsupported comparative superiority claims about generic torsemide products and misrepresent risks, the Office of Prescription Drug Promotion says in its first warning letter of 2025.
Research would include initiatives on reproducing industry-sponsored studies, postmarket surveillance, and studies of long-term neurodevelopmental and metabolic outcomes for commonly prescribed pediatric drugs.
The budget authority total, which is significantly higher than the amount floated in an April OMB draft document, suggests there may have been successful lobbying to increase FDA funding.
In this first in a series of articles looking at the potential impact of the MFN drug pricing policy on European pharmaceutical markets, EUCOPE’s Alexander Natz tells the Pink Sheet why the US policy underscores the importance of confidential net pricing.
The lack of a formal analysis of efficacy in castration-resistant prostate cancer patients without HRR mutations doomed Pfizer’s Talzenna at the US FDA's Oncologic Drugs Advisory Committee, as FDA oncology chief Richard Pazdur says chance cannot be ruled out.
The Oncologic Drugs Advisory Committee voted 5-4 that the overall benefit-risk of UGN-102 is not favorable in patients with recurrent low grade, intermediate-risk, non-muscle invasive bladder cancer and also divided on whether randomized trials should be required for future development programs.
The FDA is not currently signaling that stringent rules for the process will be relaxed, but the agency's change in approach is notable.
