Submission of Nidlegy marketing authorisation application validated by EMA
July 6, 2024
Source: drugdu
95
Philogen and Sun Pharmaceutical Industries (“Sun Pharma”) announces that on June 20 the European Medicines Agency (EMA) validated the submission of the Marketing Authorisation Application (MAA) for Nidlegy , which was finalised on June 3 2024.
“The validation of the dossier by EMA represents the first important milestone for the MAA review process,” commented Dario Neri, chief executive officer and chief scientific officer at Philogen. “Our group is committed to working with EMA throughout the review process with the goal of making Nidlegy available to patients in need.”
Nidlegy is partnered with Sun Pharma for the treatment of Skin Cancers in Europe, New Zealand and Australia.
The data of the Phase III Nidlegy trial are expected to be published in a peer-reviewed scientific journal in 2024.
https://sunpharma.com/wp-content/uploads/2024/07/Press-Release-Validation-of-Nidlegy%E2%84%A2-Marketing-Authorization-Application-Submission-by-EMA.pdf
By editor
Copyright©2024 Ddu. All rights reserved.
Read more on
- Junshi Biotechnology introduces two cancer dual target fusion protein drugs November 22, 2024
- China Biopharmaceuticals announces signing equity investment and strategic cooperation agreement with Lixin Pharmaceutical November 22, 2024
- As the industry is going down, more and more pharmaceutical companies are seeking to “exit”? November 22, 2024
- Regeneron’s midlife crisis November 22, 2024
- This “excellent hospital director” took the initiative to explain the problem November 22, 2024
your submission has already been received.
OK
Subscribe
Please enter a valid Email address！
Submit
The most relevant industry news & insight will be sent to you every two weeks.
