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Loperamide Abuse Triggers Look At Potential Label Warning

 
• By Malcolm Spicer

Monitoring of AERs prompts concern about the ingredient used in OTC anti-diarrheal products, CDER says a day after it noted adverse event reports in announcing concerns about a risk of serious bleeding linked to use of OTC antacid/aspirin products.

FDA's Center for Drug Evaluation and Research warns consumers about taking more of the anti-diarrheal drug loperamide than indicated, the center's second warning about a common OTC ingredient in as many days.

Monitoring reports of adverse events, including 10 deaths, prompts concern about the ingredient used in OTCs including McNeil Consumer...

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Merck’s Keytruda Gains Medicare Negotiation Reprieve With Expanded Orphan Exemption

 
• By Cathy Kelly

Bristol Myers Squibb’s Opdivo and Merck's Welireg also could benefit from the delay in Medicare price negotiation process eligibility.

US FDA’s Biologics Center Departures Grew Before More Than 100 RIFs Exited

 
• By Derrick Gingery

The Center for Biologics Evaluation and Research saw departures far outnumber new hires in the second and third quarters of FY 2025, before more than 100 people left July 14 after the reduction-in-force was finalized.

US FDA Cancer Reviewers Heading For The Exits, Potentially Impacting Review Timelines

 
• By Sarah Karlin-Smith

US FDA's cancer drugs division is feeling the effect of drug reviewer departures, despite efforts to keep them at the agency.

Blenrep Review Highlights US FDA Oncology Trial Site Selection, Comparator Issues

 
• By Sue Sutter

The FDA will take a hard line on trial design and site selection to ensure applicability to the US, Oncology Center of Excellence Director Richard Pazdur said during a meeting on GSK's Blenrep.

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