US FDA’s Most Controversial Drug Approval Decisions, From A To Z

Following accelerated approval of Biogen’s Alzheimer’s drug aducanumab in the US, we look back at 10 of the FDA’s most controversial drug approval decisions, from Addyi to Zohydro.

FDA approval controversies (photo illustration)
During a controversial review, sometimes all sides have pitchforks out at the US FDA • Source: Photo illustration/Alamy, Shutterstock images

The US Food and Drug Administration’s decision to grant conditional approval to Biogen Pharma and Eisai Co., Ltd.’s Alzheimer’s drug aducanumab has been met with mixed responses. 

Questions about the robustness of the efficacy data, internal FDA disagreement on the application’s merits, harsh advisory committee criticism of...

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.