Biodexa Receives Orphan Drug Designation in Europe for eRapa in FAP New designation follows the U.S. Food and Drug ...

An EU committee is recommending that tranilast, the active ingredient in a pulmonary fibrosis drug candidate, be awarded ...

The European Commission (EC) has granted orphan drug designation to Biodexa Pharmaceuticals’ oral tablet formulation of ...

If approved, eRapa will offer 10 years of market exclusivity in the EU, alongside other regulatory advantages. Biodexa has received Orphan Drug Designation in Europe for eRapa in the treatment of ...

The Orphan Drug Designation is a crucial step in securing marketing authorization within the European Union. This announcement is based on a press release statement from Biodexa Pharmaceuticals PLC.

The European Medicines Agency (EMA) has approved Moleculin Biotech’s clinical trial application (CTA) for a pivotal, ...

Positive opinion follows recent EMA Priority Medicines (PRIME) designation and FDA ... than five in 10,000 people in the European Union. Candidates for orphan designation must also offer ...

Biodexa Receives Orphan Drug Designation in Europe for eRapa in FAP New designation follows the U.S. Food and Drug Administration (FDA) Orphan Drug Designation for eRapa in FAP granted ...