Date | Compound | Laboratory | Indication | Type of Information |
---|---|---|---|---|
2015-06-10 | staphylococcal aureus protein A | Protalex (USA - NJ) | immune thrombocytopenic purpura |
Granting of the orphan status in the US |
2015-05-28 | intraventricular nimodipine | Edge Therapeutics (USA - NJ) | subarachnoid hemorrhage (ruptured brain aneurysm) |
Granting of the orphan status in the US |
2015-06-09 | isocitrate dehydrogenase 1 (IDH1)-mutant inhibitor | Agios Pharmaceuticals (USA - MA) | acute myeloid leukemia (AML) |
Granting of the orphan status in the US |
2017-06-26 | regorafenib | Bayer Healthcare (Germany) | hepatocellular carcinoma | Granting of a Market Authorisation in Japan |
2017-08-31 | tumor-infiltrating lymphocytes | Lion Biotechnologies (USA - CA), now Iovance Biotherapeutics (USA - CA) | malignant melanoma Stages IIb to IV | Granting of a Fast Track status |
2015-06-16 | pembrolizumab (MK-3475) | Merck&Co (USA - NJ) | gastric cancer, including gastroesophageal junction adenocarcinoma | Granting of the orphan status in the US |
2015-08-19 | (6aR,10aR)-3-(1,1-dimethylheptyl)-6a,7,10,10a-tetrahydro-1-hydroxy-6,6-dimethyl-6H-Dibenzo(b,d)pyran-9-carboxylic acid | Corbus Pharmaceuticals (USA - MA) | systemic sclerosis (scleroderma) |
Granting of a Fast Track status |
2015-06-01 | 17-a-hydroxyprogesterone caproate (oral formulation) | Lipocine (USA - UT) | prevention of preterm birth in women with a singleton pregnancy |
Granting of the orphan status in the US |
2015-06-01 | 2-(5-fluoro-2-methyl-1H-indol-3-yl)-1H-imidazo[4,5-f][1,10] phenanthroline | Aptose Biosciences (Canada) | acute myeloid leukemia |
Granting of the orphan status in the US |
2015-07-14 | adenovirus vaccine encoding reduced expression in immortalized cell protein | MTG Biotherapeutics (USA - CA) | mesothelioma |
Granting of the orphan status in the US |
2015-07-23 | cannabidiol | Insys Therapeutics (USA - AZ) | infantile spasms |
Granting of the orphan status in the US |
2016-04-28 | cannabidiol | Talent biotechs (Israel)/Richardson Associates Regulatory Affairs (UK) | prevention of graft-versus-host Disease (GVHD) |
Granting of the orphan status in the EU |
2015-06-23 | chlorotoxin conjugated to indocyanine green dye | Blaze Bioscience (USA - WA) | management of malignant brain tumors |
Granting of the orphan status in the US |
2015-07-14 | anisina | Novogen (Australia) | neuroblastoma |
Granting of the orphan status in the US |
2015-06-24 | gemcitabine ready-to-use | Sun Pharmaceuticals (India) | pancreatic cancer |
Granting of the orphan status in the US |
2015-06-24 | gemcitabine ready-to-use | Sun Pharmaceuticals (India) | ovarian cancer |
Granting of the orphan status in the US |
2015-07-23 | antroquinonol | Golden Biotechnology Corporation (Taiwan) | hepatocellular carcinoma |
Granting of the orphan status in the US |
2015-07-14 | melphalan | Delcath Systems (USA - NY) | cholangiocarcinoma |
Granting of the orphan status in the US |
2015-07-20 | mongersen | Celgene (USA - NJ) | pediatric Crohn\'s disease |
Granting of the orphan status in the US |
2015-07-09 | nano-diamino-tetraiodothyroacetic acid | NanoPharmaceuticals (USA - NY) | glioblastoma multiforme |
Granting of the orphan status in the US |
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