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EMA Orphan Drug Designation (ODD) builds on U.S. Food & Drug Administration (FDA) ODD and Fast Track Designation, underscoring the urgen ...
The purpose of the pharma package is to revise the current rules on medicines to make them more accessible to patients while ...
Investing.com -- Shares of Tempest Therapeutics Inc (NASDAQ: TPST) climbed 5.3% following the announcement that the European Medicines Agency (EMA) has granted Orphan Drug Designation to its cancer ...
Basel: Roche has announced that the European Commission (EC) has approved a label extension for Evrysdi (risdiplam) to ...
No. 10 / 2025 Zealand Pharma submits Marketing Authorization Application to the European Medicines Agency for glepaglutide in ...
Adding Blenrep to standard therapy prolonged progression-free survival in patients with relapsed or refractory multiple ...
European Commission approves Roche’s Evrysdi tablet to treat spinal muscular atrophy: Basel Thursday, June 5, 2025, 09:00 Hrs [IST] Roche announced that the European Commission ...