Tag: European Medicines Agency (EMA)
ARS Responds to FDA’s Request for Additional Study Before Approving neffy...
FDA Issues Complete Response Letter for neffy® New Drug Application with Request for Additional Study.
Viaskin Peanut Patch Therapy Delayed Further as DBV Readies Another Phase...
The patch therapy remains in regulatory limbo.
FDA Wants More Viaskin Peanut Data Resulting in Further Approval Delays
Delays mount pushing trials of modified patch.
Emergency Epinephrine Nasal Spray Takes Final Step Toward Approval in EU
A needle-free option for administration of epinephrine is on the horizon.
Viaskin Peanut “Patch” Therapy Takes Next Step Toward Approval… in Europe
The Marketing Authorization Application for Viaskin™ Peanut was validated by the European Medicines Agency.
Results of Aimmune’s Pivotal Phase 3 European Trial of PALFORZIA® Published...
Peanut-allergic patients treated with Palforzia showed desensitization to peanut protein with a predictable safety profile at nine months
