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Project Optimus For Kids: US FDA Aims To Improve Dosage Optimization For Pediatric Cancer Drugs

 
• By Sue Sutter

Pediatric studies of promising cancer drugs can begin before the ideal dose is identified for adults, although some dose optimization work in children may be better left to the postmarket setting, advisory committee members said.  

Childhood cancer
Cancer drug studies in children do not have to wait until an optimized dose is identified in adults. • Source: Shutterstock

Pediatric studies of promising cancer drugs can begin before an optimized dosage is identified for adults, but there should be a prospect for clinical benefit in pediatric patients and, ideally, an age-appropriate formulation, the US Food and Drug Administration and its external experts said at a recent advisory committee meeting.

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AMR-Targeting Drug Secures EMA PRIME Designation

 
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US FDA’s March Approval Candidates Take Aim At Established Markets

 
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March features nearly 20 user fee goal dates, including a crowd of novel candidates for crowded areas like hemophilia, heart disease and urinary tract infections, as well as the potentially first therapies for a rare eye disease and hyperphagia of Prader-Willi syndrome.

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‘Pipeline In A Pill’ Or Pipe Dream? US FDA’s April Goal Dates Test Expansion Strategies

 
• By Bridget Silverman

Sanofi’s Dupixent, Amgen’s Uplizna, and Bristol’s Opdivo seek new indications, while J&J hopes to start a franchise with nipocalimab and Stealth’s day of reckoning approaches.

Global Pharma Guidance Tracker – February 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.

EU CHMP Opinions And MAA Updates

 
• By Neena Brizmohun

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.