1. Pink Sheet

Break-Point: FDA Committee Votes To Restrict Quinolones, But Does Not Endorse Disability Syndrome

 
• By Laura Helbling

An FDA advisory committee review of quinolone antibiotic safety focused on a very old safety issue – but points to a new era in antibiotic development, and restricted use models.

One way of describing the Nov. 5 meeting of FDA’s Antimicrobial Drugs and Drug Safety & Risk Management Advisory Committees focused on a long-standing safety concern with a very widely used class of drugs.

Critics of the quinolone class—including Public Citizen—have advocated for labeling changes and product withdrawals for two decades, asserting that the...

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EMA Explores Supporting Drug Development For High Unmet Need Disorder Scleroderma

 
• By Neena Brizmohun

While treatments for scleroderma are in development, none are approved for the condition that is associated with high morbidity and mortality. The European Medicines Agency says guidance on how to design development programs for the disorder is needed.

EMA Nod For First MASH Drug Rezdiffra, Cell Therapy Zemcelpro And 11 Others

 
• By Eliza Slawther

Madrigal Pharmaceuticals’ Rezdiffra is on track to become the first medicine approved in the EU for non-cirrhotic metabolic dysfunction-associated steatohepatitis after the European Medicines Agency recommended that it be granted conditional marketing authorization.

BIO Notebook: Policy Uncertainty Constraining Dealmaking

 
• By Mandy Jackson and Joseph Haas

Highlights from Day Four of the BIO International Convention include policy concerns helping constrain dealmaking, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.