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F2G Receives Orphan Drug Designation for Olorofim americanpharmaceuticalreview
March 10, 2020
F2G announced the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its lead first-in-class candidate, olorofim (formerly F901318) for treatment of invasive aspergillosis ...
FDA Grants Orphan Drug Designation for Progressive SupraNuclear Palsy Treatment americanpharmaceuticalreview
March 09, 2020
Retrotope announced the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development granted orphan drug designation for its chemically-modified polyunsaturated fatty acid drug (RT001) ...
BioLineRx Receives Orphan Drug Designation for Motixafortide for Pancreatic Cancer in Europe americanpharmaceuticalreview
January 19, 2020
BioLineRx announced the European Commission (EC) has granted Orphan Drug Designation to its lead oncology candidate, Motixafortide (BL-8040), for the treatment of pancreatic cancer, based on a positive opinion from the Committee for ...
Acute myeloid leukemia treatment receives FDA Orphan Drug Designation europeanpharmaceuticalreview
January 09, 2020
Orphan drug designation has been approved by the FDA for PRGN-3006 UltraCAR-T™ for patients with acute myeloid leukemia (AML).
FDA Grants Avatrombopag Orphan Drug Designation americanpharmaceuticalreview
December 24, 2019
Dova Pharmaceuticals has been granted Orphan Drug Designation (ODD) by the US Food and Drug Administration (FDA) for avatrombopag for the potential treament of Chemotherapy-Induced Thrombocytopenia (CIT).
EC grants orphan drug status to Dicerna’s DCR-A1AT to treat congenital A1AT deficiency pharmaceutical-business-review
December 20, 2019
Dicerna Pharmaceuticals has secured orphan drug designation from the European Commission (EC) for its DCR-A1AT to treat congenital alpha-1 antitrypsin (A1AT) deficiency.
FDA grants Orphan Drug Designation to Epidermolysis Bullosa treatment europeanpharmaceuticalreview
December 10, 2019
The US Food and Drug Administration has awarded APR-TD011 Orphan Drug Designation, for the treatment of a rare disease.
Glenmark receives Orphan Drug Designation for GBR 1342 biospectrumasia
September 18, 2019
Derived from the company’s proprietary BEAT® (Bispecific Engagement by Antibodies based on the T cell receptor) technology, GBR 1342 is being investigated for the treatment of multiple myeloma.
anti-BCMA autologous CAR-T cells (CT053) receives US FDA orphan drug designation biospectrumasia
September 03, 2019
Under the Orphan Drug Act, the CT053 anti-BCMA product would be eligible for certain benefits including seven years of market exclusivity in the United States following marketing approval by the FDA.
Neuropore Receives Orphan Drug Designation for ALS Treatment americanpharmaceuticalreview
August 15, 2019
Neuropore Therapies has received orphan drug designation for NPT520-34 for the treatment of amyotrophic lateral sclerosis or ALS. The orphan drug designation will facilitate the development of NPT520-34 in the treatment of this debilitating medical condit

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