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EMA granted Orphan Designation to Aldeyra's drug, following prior FDA designation.

4 reports, 3 independent Updated Aug 28
Gone quiet Reached 3 outlets in its first 24 hours
Reports
4
Developments
3
Repetition
50%

New informationRepeats or wire copies

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What happened

Well supportedReported by 3 independent outlets

EMA granted Orphan Designation to Aldeyra's drug, following prior FDA designation.

Who's involved

What this event is mainly about
Alena Kohušová

How it developed

Newest first. Tap a step to see who reported it.
  1. Aldeyra Therapeutics received fast track designation from the FDA for its drug candidate ADX-2191 targeting Retinitis Pigmentosa.Sub-event
  2. Aldeyra Therapeutics received Orphan Designation from the EMA.1 source
  3. OS Therapies continues its regulatory journey with positive feedback from MHRA and an EMA SAM meeting.1 source

Keep exploring

The entities involved

Coverage

Newest first; wire copies grouped
  • Business WireAldeyra Therapeutics Receives Orphan Designation from the European Medicines Agency for ADX-2191 for the Treatment of Primary Large B-Cell Lymphomas of Immune-Privileged Sites, including Primary Vitre
  • NewsfileOS Therapies Receives Positive Feedback from UK MHRA Scientific Advice Meeting and Submits Innovative Licensing and Access Pathway (ILAP) Request for OST-HER2 in the Prevention or Delay of Recurrent,
  • Business WireAldeyra Therapeutics Receives Orphan Designation from the European Medicines Agency for ADX-2191 for the Treatment of Inherited Retinal Dystrophies including Retinitis Pigmentosa LEXINGTON, Mass., Ju
  • GlobeNewswireValneva Announces Lifting of European Medicines Agency’s Temporary Restriction on Use of Chikungunya Vaccine IXCHIQ® in Elderly Saint Herblain (France), July, 11 2025 – Valneva SE (Nasdaq: VALN; Euro