Keeping Track: A Lawsuit-Driven Complete Response Letter, A Refuse To File Letter, And Some Good News

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

Keeping Track Feature image

Here’s your US FDA review and approval news in brief this week: BioMarin Pharmaceutical Inc.’s Voxzogo and PharmaEssentia Corporation’s Besremi stand out among the FDA’s recent approvals as the first drugs indicated for achondroplasia and polycythemia vera, respectively.

The agency also approved a new adjuvant renal cell carcinoma indication for

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

More from Regulatory Trackers