Drugs.com New Drug ApplicationsOriginal article
Cemdisiran Regulatory Submissions Accepted for Review by FDA and EMA for the Treatment of Generalized Myasthenia Gravis (gMG)
NDA FilingCemdisiranPositive
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Summary
Regeneron announced that the FDA and EMA have accepted regulatory applications for Cemdisiran for the treatment of generalized myasthenia gravis. The drug is now under review by both regulatory agencies.
Outcome Details
Regulatory applications accepted for review by FDA and EMA
Importance:7/10
Sentiment:
0.60
FDAEMAregulatory submissionneurologymyasthenia gravis
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Published by Drugs.com New Drug Applications on June 22, 2026 8:06 AM