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FDA Indicates Optimism Prevnar 13 Will Show Clinical Benefit In Confirmatory Trial

 
• By Derrick Gingery

Advisory committee votes 14-1 in favor of effectiveness and safety in adults 50 and older.

FDA appears supremely confident that Pfizer Inc.’s Prevnar 13 pneumonia vaccine will confirm its clinical benefit in adults and is worthy of accelerated approval.

The company is looking to gain accelerated approval to use the pneumococcal 13-valent conjugate vaccine in adults age 50 and...

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More from US FDA Performance Tracker

August Brings Fresh Faces And Tough Calls To US FDA User Fee Calendar

 
• By Bridget Silverman

The FDA could act on 17 applications, including 10 novel agents, during August. Only one would be a second-cycle review.

Complete Response Letter Trio Raises Prospect Of Tidal Shift In Regenerative Medicine Regulation

 
• By Bridget Silverman

Replimune's RP1 oncolytic immunotherapy became the third regenerative medicine to receive an FDA complete response letter this month as the agency appears to re-visit previous agreements about accelerated approval.

US FDA’s Second Half 2025 User Fee Goals Swing Toward Respiratory Disease

 
• By Bridget Silverman

The 43 novel agents with user fee goal dates in the remainder of 2025 have fewer oncologics and infectious disease drugs than the first half of the year.

Slowdown: US FDA’s 2025 Novel Approvals Are On Below-Average Pace

 
• By Bridget Silverman

US FDA's 25 novel approvals in 2025 fell short of the agency's five-year average count, driven by a drop in drugs center approvals; 45 user fee goals remain in second half of year.

More from Regulatory Trackers

US FDA’s Second Half 2025 User Fee Goals Swing Toward Respiratory Disease

 
• By Bridget Silverman

The 43 novel agents with user fee goal dates in the remainder of 2025 have fewer oncologics and infectious disease drugs than the first half of the year.

Slowdown: US FDA’s 2025 Novel Approvals Are On Below-Average Pace

 
• By Bridget Silverman

US FDA's 25 novel approvals in 2025 fell short of the agency's five-year average count, driven by a drop in drugs center approvals; 45 user fee goals remain in second half of year.

Global Pharma Guidance Tracker - June 2025

 
• By Vibha Sharma and Anabel Costa-Ferreira

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.