因塞特医疗高管透露:FDA一月告知公司,Opzelura需进行额外疗效研究方可获批结节性痒疹适应症

美股速递
Feb 10

因塞特医疗高管近日披露,美国食品药品监督管理局已于今年1月正式通知公司,其研发的Opzelura药物在获批用于治疗结节性痒疹之前,必须完成另一项疗效验证研究。这一要求意味着该药物针对此适应症的上市进程将面临新的监管审查环节。

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

Most Discussed

  1. 1
     
     
     
     
  2. 2
     
     
     
     
  3. 3
     
     
     
     
  4. 4
     
     
     
     
  5. 5
     
     
     
     
  6. 6
     
     
     
     
  7. 7
     
     
     
     
  8. 8
     
     
     
     
  9. 9
     
     
     
     
  10. 10