gamesthatusecrypto| Eisai and Biojian: Launch Leqembi drug rolling application, FDA approval is under way

News summary

Japan Eisai and Biojian cooperate to submit a marketing application for Alzheimer's disease drug Leqembi for subcutaneous injectiongamesthatusecrypto, is undergoing the FDA rolling data evaluation phase.

Newsletter text

[Eisai and Biojian Submit Leqembi Drug Marketing Applications] Japanese drug manufacturer Eisai and partner Biojian have begun submitting rolling data to the U.S. Food and Drug Administration (FDA)gamesthatusecrypto, with a view to obtaining approval for the subcutaneous injection version of the Alzheimer's treatment drug Leqembi.

The two companies are seeking FDA approval of Leqembi as a weekly subcutaneous drug. Through a rolling submission mechanism, regulators will evaluate data immediately after receiving it until the amount of data is sufficient to make a formal listing request.

Eisai temporarily shelved Leqembi's marketing application in April after the FDA asked it to provide an additional three months of immunogenicity data.

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