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Big Pharma Companies Have Higher US FDA Approval Percentage Than Everybody Else

 
• By Bridget Silverman

Almost 80% of novel agent submissions from the biggest companies were approved in recent years, compared with a 60% approval rate for the rest of the industry, according to a recent analysis of FDA approval decisions since 2021.

FDA Approved typed words on a vintage typewriter

A beneficial effect of sponsorship by the largest companies in the pharma industry can be seen in the fates of novel agent applications that faced US FDA approval decisions in recent years: the applications associated with big pharma were approved at a higher rate than novel agent NDAs and BLAs attached to mid-sized and small firms, an analysis of Pink Sheet’s US FDA Performance Tracker shows.

A little more than one-quarter of the FDA’s decisions on novel agent applications with user fee goal dates in 2021, 2022 and the first four months of 2023 were associated with one of the 15 biggest

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