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Consistency, Not Fireworks: US FDA’s Novel Approvals Times Stick Close To PDUFA Schedule

 
• By Bridget Silverman

CDER holds steady with a median time to approval of 11 months, while CBER posts 10.5 month median review time for its largest novel approvals class.

Fireworks-with-banned-symbol
• Source: Shutterstock

The sheer number of US FDA’s novel drug approvals in 2023 contrasts with the generally moderate, steady performance of the Center for Drug Evaluation and Research over the year, including a median review time of 11 months that matched 2022.

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AMR-Targeting Drug Secures EMA PRIME Designation

 
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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.

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

 
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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.

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

 
• By Bridget Silverman

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

 
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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.