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Fluoroquinolones Need REMS With Communication Plan, AdCom Says

 
• By Derrick Gingery

Overwhelming votes against existing labels for the antibiotics likely means sponsors and FDA have some safety planning to do.

Fluoroquinolones once again need a Risk Evaluation and Mitigation Strategy to ensure providers and patients understand the risks of the medication, several advisory committee members said.

Members of the joint Antimicrobial Drugs and Drug Safety and Risk Management advisory committees offered a REMS as a way...

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More from United States

US FDA Teases Disclosure Program, But Industry Has Seen This Before

 
• By Derrick Gingery

Center for Biologics Evaluation and Research Director Vinay Prasad said Commissioner Martin Makary wants to release previously inaccessible FDA documents, but previous commissioners have made the same pronouncements only to make little progress.

US FDA’s July AdComms: Pediatric Vaccine Safety, Blenrep’s Return, (Maybe) Capricor’s Cell Therapy

 
• By Sue Sutter

The Pediatric Advisory Committee will review postmarketing safety for three vaccines and the oncologic drugs panel will consider the return of GSK’s belantamab mafodotin. An FDA notice about a 30 July meeting on Capricor’s deramiocel for Duchenne muscular dystrophy was withdrawn.

Elevidys Helps Sarepta To First US FDA Platform Technology Designation

 
• By Bridget Silverman

Sarepta's rAAVrh74 vector, used in the marketed Duchenne muscular dystrophy gene therapy Elevidys and across the company's limb girdle muscular dystrophy pipeline, earned a platform designation as the lead LGMD candidate prepares for BLA filing.

Pink Sheet Podcast: The US and Ex-US Impact Of Most-Favored Nation Drug Pricing

 
• By Derrick Gingery, Francesca Bruce, Cathy Kelly, and Nielsen Hobbs

Pink Sheet reporter and editors discuss the potential impact of the Most-Favored Nation drug pricing proposal on Europe, the United States, as well as the pharmaceutical industry.

More from North America

Recent And Upcoming FDA Advisory Committee Meetings

 
• By Sue Sutter

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

US FDA Could Miss User Fee Spending Triggers With House FY 2026 Funding

 
• By Sarah Karlin-Smith and Derrick Gingery

FDA employees are concerned that while the budget authority total proposed for fiscal year 2026 meets the user fee appropriations' triggers, the FDA could have trouble meeting allocation triggers without cuts to non-review work.

PCMA, CVS, Cigna File Lawsuits Over ‘Dangerous’ Arkansas PBM Law

 
• By Tim Casey

The suits are an early test of the Arkansas law banning company ownership of PBMs and pharmacies in the state, as other states consider similar legislation.