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

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.

Sponsors are hoping approvals will blossom along with the cherry trees. (Shutterstock)
Key Takeaways
  • Six novel agents are due for FDA decisions in April 2025, stemming from different disease areas such as ophthalmology, immunology, vaccines, cancer imaging, and cardio-metabolic disease.

“Pipeline in a pill”-style drug development will be on display in April, when more than half of the user fee...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet 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 US FDA Performance Tracker

Precigen’s Papzimeous Approval Allows US FDA CBER Director To Emphasize Flexibility

 

Returning FDA biologics center director Vinay Prasad used the Papzimeous approval announcement to reinforce his flexibility on rare disease therapies after several complete response letters and his brief departure from the agency.

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

 

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

 

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

 

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.

More from Pathways & Standards

EMA Revives Face-To-Face Oral Explanations In Response To Industry Feedback

 
• By 

The European Medicines Agency is bringing back in-person oral explanation meetings with drug sponsors on a pilot basis, following industry feedback that direct engagement with its scientific committees is highly valued.

New EU Filings

 

Ensitrelvir, Shionogi's treatment for COVID-19, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

With Thyroid Petition Win, AbbVie Snares Itself; US FDA Sets Up Another Compounding Fight

 
• By 

AbbVie didn’t get everything it sought from a citizen petition but may still have the upper hand over smaller rivals after FDA gives makers of animal-derived thyroid medications a year to seek approval. If the agency removes compounded products, it could face more pricing pushback.