European Medicines Agency (EMA) Archives

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Tag: European Medicines Agency (EMA)

FDA Delays Approval of Aquestive’s Anaphylm™ Sublingual Epinephrine Film

DBV Announces Positive Regulatory Updates for the Viaskin® Peanut Patch in the...

EU Poised to Approve First Nasal Epinephrine Treatment for Anaphylaxis

ARS Completes Repeat Dosing Study of Nasal Epinephrine Required by FDA...

ARS Responds to FDA’s Request for Additional Study Before Approving neffy...

Viaskin Peanut Patch Therapy Delayed Further as DBV Readies Another Phase...

FDA Wants More Viaskin Peanut Data Resulting in Further Approval Delays

Emergency Epinephrine Nasal Spray Takes Final Step Toward Approval in EU

Viaskin Peanut “Patch” Therapy Takes Next Step Toward Approval… in Europe

Results of Aimmune’s Pivotal Phase 3 European Trial of PALFORZIA® Published...

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