Keeping Track: A Fresh Wave Of Approvals

The latest drug development news and highlights from our US FDA Performance Tracker.

Keeping Track Feature image

 Approvals galore was the theme of the week, as the US FDA issued a series of positive decisions in a long lineup of user fee goal dates. Here's your news in brief:

On the new molecular entity (NME) front, the agency gave its blessing to Ultragenyx Pharmaceutical Inc.'s X-linked hypophosphatemia (XLH)...

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 Product Reviews

More from Pink Sheet

Recent And Upcoming FDA Advisory Committee Meetings

 
• By 

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

UK-Wide Strategy Needed To Move Clinical Trial Diversity Plans To Next Stage

 
• By 

The UK’s research-based pharma industry and medical research charities have set out clear action points to drive greater diversity and inclusion in clinical trials.

Blenrep’s Comeback Continues As England Becomes First To Fund Drug

 

Blenrep, GSK’s multiple myeloma therapy, faced a major setback when it was withdrawn from the market in 2022. The drug has since made a return as a second-line therapy, and is on track to being reimbursed in England.