1. Pink Sheet
  2. >>Product Reviews

On The Docket: Recent Submissions For US FDA Approval

 
• By Bridget Silverman

Round-up of late summer applications recently submitted to US FDA, adapted from the Pink Sheet FDA Performance Tracker's User Fee Goal Dates chart.

Below is a table from of recent NDA and BLA applications to the US Food and Drug Administration based on data from the Pink Sheet’s FDA Performance Tracker. As one might expect, special pathways figure prominently in the submissions.

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
Start Free Trial

Already a subscriber?

More from Product Reviews

J&J’s Inlexzo Is A Rare 505(b)(2) NDA To Qualify For US FDA’s Real-Time Oncology Review

 
• By Bridget Silverman

A Johnson & Johnson executive tells the Pink Sheet in an interview how the company developed its pretzel-shaped intravesical drug releasing system for gemcitabine, which used design and materials to improve efficacy and ease bladder cancer treatment.

US FDA Complete Response Letters Offer ‘Path Forward’ To Approval

 
• By Sue Sutter

Recently released CRLs for unapproved products contain recommendations for new studies, including design element details and advice to consider different submission pathways.

ICH’s M14 Guideline Sets Global Standard For Non-Interventional RWD Studies

 
• By Vibha Sharma

A new guideline finalized by the International Council of Harmonisation is expected to reshape how non-interventional drug safety studies use real-world data, bringing clarity, consistency, and global alignment.

Sanofi’s Rilzabrutinib & Belumosudil Among Seven Drugs Facing EMA Oral Explanations

 
• By Vibha Sharma

The sponsors of seven new medicines nearing the end of their EU regulatory review are due – or possibly due – to appear before the European Medicines Agency’s human medicines committee, the CHMP, to address remaining concerns about their marketing applications.

More from Pink Sheet

Canada, Britain And Australia Push For Greater International Regulatory Alignment

 
• By Eliza Slawther

Canada’s drug regulator is using amended drug laws to increase the use of regulatory reliance pathways to improve efficiency and support international alignment, while the UK’s MHRA has held talks with Australia’s TGA on topics including the role of AI in regulatory frameworks.

Publisher’s Spotlight: Shortlist Unveiled For Citeline Japan Awards

 
• By Ian Haydock

Shortlists of potential winners in all categories of the Citeline Japan Awards 2025 have now been released. Join us at the event in Tokyo on October 21, it’s not too late to book your table!

Ex-CDC Leaders Reveal New Details Of Kennedy’s Plans For ACIP, Vaccine Schedule

 
• By Sarah Karlin-Smith

The former CDC director and recently departed chief medical officer tell senators that Kennedy plans to target the childhood vaccine schedule despite a lack of scientific data to support his agenda.