Aldeyra Therapeutics收到美国FDA就Reproxalap干眼症新药申请发出的完整回复函

美股速递
Mar 17

Aldeyra Therapeutics宣布,已收到美国食品药品监督管理局(FDA)针对其Reproxalap新药申请(NDA)发出的完整回复函(CRL)。该申请旨在寻求批准Reproxalap用于治疗干眼病的体征和症状。完整回复函通常意味着FDA在当前阶段不会批准该申请,并会指出需要补充的信息或存在的问题。公司表示正在评估该函件内容,并将与FDA密切沟通,以确定后续步骤。

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