Tag: European Medicines Agency (EMA)

Viaskin Patch

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

The patch therapy remains in regulatory limbo.
Viaskin Peanut

FDA Wants More Viaskin Peanut Data Resulting in Further Approval Delays

Delays mount pushing trials of modified patch.
Intranasal Spray

Emergency Epinephrine Nasal Spray Takes Final Step Toward Approval in EU

A needle-free option for administration of epinephrine is on the horizon.
Viaskin Patch

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.
Palforzia Capsules with Logo

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