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FDA’s Fecal Transplant Enforcement Discretion May Jeopardize Rebiotix’s Approval Prospects

 
• By Sarah Karlin-Smith

A 2013 FDA decision to allow certain fecal microbiota transplants for C. difficile infection without an investigational new drug application hurt Rebiotix’s Phase III trial enrollment and may ultimately leave it without strong enough data for advisory committee endorsement or FDA approval.

person clutching stomach
Rebiotix’s fecal microbiota transplant looks to face uphill fight at FDA advisory committee 22 September • Source: Shutterstock

Ferring Pharmaceuticals’s fecal microbiota transplant product looks to be facing an uphill battle for US Food and Drug Administration approval due in part to an FDA policy that complicated the company’s ability to conduct two placebo-controlled Phase III trials.

Rebyota, or RBX2660, will go before the agency’s Vaccines and Related Biological Products Advisory Committee on 22 September seeking approval for a fecal microbiota enema to reduce the recurrence of

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Keep Talking: US FDA’s Beleaguered Biologics Center Remains Vital To Regenerative Medicine

 
• By Bridget Silverman

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Maybe In May: US FDA Calls Coming On Moderna Next-Gen COVID-19 Vaccine, AbbVie’s Big ADC Bet

 
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AMR-Targeting Drug Secures EMA PRIME Designation

 
• By Neena Brizmohun

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US FDA’s Review Performance Held Steady Despite Stormy First Quarter

 
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Organizational turmoil has not yet affected reviews of novel agent applications, with Q1 2025 approvals coming in low, but the first quarter share of the entire year is variable.

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AMR-Targeting Drug Secures EMA PRIME Designation

 
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Antabio’s next-generation, broad-spectrum antibacterial, MEM-ANT3310, has made it onto the European Medicines Agency’s priority medicines scheme. The company says its product is designed to make a significant impact on the growing problem of antimicrobial resistance.

Global Pharma Guidance Tracker - March 2025

 
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Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

US FDA’s Review Performance Held Steady Despite Stormy First Quarter

 
• By Bridget Silverman

Organizational turmoil has not yet affected reviews of novel agent applications, with Q1 2025 approvals coming in low, but the first quarter share of the entire year is variable.