Actuate Therapeutics has gained orphan medicinal product designation (OMPD) from the European Medicines Agency (EMA) for ...
Inc. (NASDAQ: ACTU) (“Actuate” or the “Company”), a clinical-stage biopharmaceutical company focused on developing therapies ...
Actuate Therapeutics (ACTU) announced that the European Medicines Agency, EMA, has granted Orphan Medicinal Product Designation, OMPD, to ...
Neurizon recently received EMA orphan designation for NUZ-001 to treat ALS and filed an FDA IND application to begin a phase ...
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 ...