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SpringWorks receives orphan status for nirogacestat in Europe pharmaceutical-technology
September 27, 2019
US-based SpringWorks Therapeutics has received orphan drug designation from the European Commission (EC) for its small molecule candidate nirogacestat to treat soft tissue sarcoma.
EC Grants Orphan Drug Designation for Nirogacestat for Soft Tissue Sarcoma americanpharmaceuticalreview
September 25, 2019
SpringWorks Therapeutics announced the European Commission has granted Orphan Drug Designation for nirogacestat, an oral, selective, small molecule, gamma-secretase inhibitor, for the treatment of soft tissue sarcoma.
FDA Grants Orphan Drug Designation to Reneo for REN001 americanpharmaceuticalreview
September 23, 2019
Reneo Pharmaceuticals announced the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development has granted Orphan Drug Designation to the company's lead drug candidate ...
Multiple myeloma treatment granted Orphan Drug Designation europeanpharmaceuticalreview
September 19, 2019
Orphan Drug Designation has been given to bispecific antibody candidate, GBR 1342, for the treatment of multiple myeloma.
Glenmark Receives Orphan Drug Designation for Multiple Myeloma Candidate americanpharmaceuticalreview
September 18, 2019
Glenmark announced the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to its bispecific antibody candidate GBR 1342 for the treatment of patients with multiple myeloma ...
FDA grants Orphan Drug Designation to sotatercept europeanpharmaceuticalreview
September 16, 2019
Orphan Drug Designation has been given to sotatercept for the treatment of patients with pulmonary arterial hypertension.
Cyxone Explores Orphan Drug Designation for Rabeximod americanpharmaceuticalreview
September 09, 2019
Cyxone announced the company's board of directors has decided to explore the possibilities of an orphan drug designation (ODD) of the drug candidate Rabeximod.
Fasenra Granted Orphan Drug Designation americanpharmaceuticalreview
September 03, 2019
AstraZeneca announced the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Fasenra (benralizumab) for the treatment of eosinophilic oesophagitis (EoE).
Multiple myeloma treatment receives Orphan Drug Designation europeanpharmaceuticalreview
September 03, 2019
Orphan drug designation has been granted to the CT053 anti-BCMA CAR-T program for multiple myeloma treatment.
AC Immune, UPenn to Research TDP-43 in Neurodegenerative Diseases contractpharma
August 14, 2019
TDP-43, a DNA-binding protein, is a target of growing interest for neuro-orphan indications.

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