在美国食品药品管理局拒绝了新的快速通道后,Disc Medicine 将寻求传统的美国审批途径

路透中文
Feb 17
在<a href="https://laohu8.com/S/USFD">美国食品</a>药品管理局拒绝了新的快速通道后,<a href="https://laohu8.com/S/IRON">Disc Medicine</a> 将寻求传统的美国审批途径

路透2月17日 - Disc Medicine IRON.O周二表示,在美国食品和药物管理局拒绝批准 (link) 新的快速通道审查计划后,该公司将为其罕见病药物寻求传统的美国审批途径。 这种名为比托哌汀(bitopertin)的药物之前是根据食品和药物管理局的国家优先凭单计划进行审查的,该计划将审批过程从通常的10-12个月缩短到1-2个月。

(为便利非英文母语者,路透将其报导自动化翻译为数种其他语言。由于自动化翻译可能有误,或未能包含所需语境,路透不保证自动化翻译文本的准确性,仅是为了便利读者而提供自动化翻译。对于因为使用自动化翻译功能而造成的任何损害或损失,路透不承担任何责任。)

At the request of the copyright holder, you need to log in to view this content

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