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

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,...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on In Vivo for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Market Intelligence

Tackling Fraud In The UK: Pharma, Are You Ready?

 
• By 

UK pharma faces a critical turning point as the Economic Crime and Corporate Transparency Act introduces the "Failure to Prevent Fraud" offense in September 2025, requiring companies to transform their approach to fraud prevention or face severe consequences.

Finding The Fire: AltruBio’s Novel Approach To Autoimmune Disease

 
• By 

CEO Judy Chou brings big pharma experience to tackle chronic inflammation with the company's first-in-class PSGL-1 targeting therapy.

Late-Stage GLP-1 Drug Trials Outside The Cardiometabolic Space

 
• By 

A look at Novo Nordisk, Eli Lilly and other companies' late-stage clinical studies of GLP-1 drugs in indications ranging from neurodegeneration to oncology, and alcoholic liver disease to autoimmune conditions.

UK Bets On Regulatory Innovation As Competitive Advantage In Synthetic Biology

 
• By 

The UK government has prioritized synthetic biology and created a "concierge service" for biotechs just as the US cuts science funding.

More from In Vivo

AI In Health Delivery: Patients Most Confident When HCPs Are In Charge

 
• By 

Annual survey of patients and professionals shows how attitudes to health system transformation are evolving and what stakeholders are demanding as acceptance of AI tools accelerates.

Medtech Innovators Court London-Based Investors At BioWales 2025

 
• By 

BioWales in London 2025 showcased the efforts healthtech innovators are making to meet investors on their own turf, illustrating changing attitudes and evolving needs.

Rising Leaders 2025: Metsera’s Whit Bernard’s Musical Path To Biotech Leadership

 
• By 

Metsera CEO Whit Bernard applies an unconventional leadership philosophy to develop next-generation obesity therapeutics, including monthly GLP-1 injections and oral peptides.