Actuate Therapeutics has gained orphan medicinal product designation (OMPD) from the European Medicines Agency (EMA) for elraglusib to treat pancreatic ductal adenocarcinoma (PDAC). The glycogen ...

With limited treatment options available for patients with PDAC, the EMA Orphan Drug Designation and FDA Orphan Drug Designation granted to elraglusib for the same indication reflect elraglusib’s ...

Neurizon was recently granted orphan medicinal product designation (OMPD) by the European Medicines Agency (EMA) for its lead drug candidate, NUZ-001, for the treatment of amyotrophic lateral ...

Azafaros B.V. today announced that its lead asset, nizubaglustat, has been granted orphan drug designation from regulatory authorities in both the United States and the European Union for the ...

An OMPD provides a robust framework of benefits, including reduced regulatory fees, free protocol assistance, and market exclusivity for 10 years in the EU upon product approval. During this ...