Sue Sutter

2 weeks ago | insights.citeline.com | Derrick Gingery |Sarah Karlin-Smith |Sarah Karlin-Smith |Sue Sutter |M. Nielsen Hobbs

Pink Sheet Podcast: US FDA’s Big Vaccine Policy WeekPink Sheet reporter and editors discuss the new clinical trial requirements that the FDA announced for COVID-19 vaccines, the updated label for Novavax’s newly approved COVID-19 vaccine, and other vaccine-related events that were part of a busy week for policy in the sector. How will the new FDA COVID-19 vaccine development framework impact the Pfizer/BioNTech and Moderna products? • Source: Citeline/Shutterstock

2 weeks ago | insights.citeline.com | Sue Sutter

Sarfez Pharma’s Promotional Claims For Diuretic Soaanz Draw US FDA Warning Letter 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. Claims that Soaanz does not cause excessive urination are not supported, FDA said. (Shutterstock)

2 weeks ago | insights.citeline.com | Sue Sutter

UroGen’s Bladder Cancer Drug Draws Split Decision From US FDA Panel 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. An FDA advisory committee was divided on UroGen's application for bladder cancer, as well as future approval standards. (Shutterstock)

2 weeks ago | insights.citeline.com | Sue Sutter

STARGLO Dulled: Genentech’s Columvi Data Not Generalizable To US Patients, FDA Panel Says The glofitamab trial results are not generalizable due to the small number of enrolled US lymphoma patients and adverse results across multiple endpoints for patients from non-Asian regions, the Oncologic Drugs Advisory Committee said. Commissioner Makary and CBER Director Prasad stopped by the 20 May ODAC meeting. (Sue Sutter)

2 weeks ago | insights.citeline.com | Sue Sutter

UroGen’s Mitomycin: Are Randomized Trials For Bladder Cancer Necessary? The Oncologic Drugs Advisory Committee will vote on the risk-benefit of UGN-102 for low-grade, intermediate-risk, non-muscle invasive bladder cancer based on data from a single-arm trial, but the FDA also seeks input on requiring randomized studies for future treatments. Is a randomized trial a better fit for some bladder cancers? (Shutterstock)