Date | Compound | Laboratory | Indication | Type of Information |
---|---|---|---|---|
2015-09-04 | Chugai Pharmaceutical (Japan) | hemophilia A with factor VIII inhibitors |
Granting of the Breakthrough Therapy status | |
2013-07-18 | idursulfase | Armagen (USA - CA) | mucopolysaccharidosis II (MPS II, Hunter Syndrome) |
Granting of the orphan status in the US |
2015-08-05 | varlitinib | Aslan Pharmaceuticals (Singapore) | cholangiocarcinoma |
Granting of the orphan status in the US |
2016-01-15 | (S)-N-(5-((R)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate | Loxo Oncology (USA - CT) | soft tissue sarcoma | Granting of the orphan status in the EU |
2017-07-20 | nivolumab | BMS (USA - NY) | hepatocellular carcinoma | Withdrawal of a market application in the EU |
2015-08-27 | nivolumab | BMS (USA - NY) | glioblastoma |
Granting of the orphan status in the US |
2015-07-21 | fostemsavir | BMS (USA - NY) | HIV-1 infection in heavily treatment-experienced adult patients |
Granting of the Breakthrough Therapy status |
2015-08-25 | adeno-associated virus serotype rh10 vector encoding the human factor IX gene | Dimension Therapeutics (USA - MA) | hemophilia B |
Granting of the orphan status in the US |
2015-08-25 | fostamatinib disodium | Rigel Pharmaceuticals (USA - CA) | immune thrombocytopenic purpura |
Granting of the orphan status in the US |
2015-10-09 | 3-[5-(2-fluoro-phenyl)-[1,2,4]oxadiazole-3-yl]-benzoic acid | PTC Therapeutics (USA - NJ) | aniridia |
Granting of the orphan status in the EU |
2015-08-20 | daratumumab | Janssen Research & Development, a J&J company (USA - NJ) | mantle cell lymphoma |
Granting of the orphan status in the US |
2015-08-06 | daratumumab | Janssen Research & Development, a J&J company (USA - NJ) | follicular lymphoma |
Granting of the orphan status in the US |
2015-08-27 | methotrexate oral solution | Silvergate Pharmaeuticals (USA - CO) | oligoarticular juvenile idiopathic arthritis (persistent oligoarthritis, psoriatic juvenile idiopathic arthritis, enthesitis-related arthritis, or undifferentiated arthritis) and polyarticular juvenile idiopathic arthritis in children 0 through 16 years of age |
Granting of the orphan status in the US |
2015-09-03 | hydrocortisone modified release capsules | Diurnal Limited (UK) | adrenal insufficiency | Granting of the orphan status in the US |
2015-09-01 | modified a-cobratoxin | Nutra Pharma (USA - FL) | pediatric multiple sclerosis (0 through 16 years of age) |
Granting of the orphan status in the US |
2015-08-03 | afatinib | Boehringer Ingelheim (Germany) | non-small cell lung cancer with squamous histology | Granting of the orphan status in the US |
2015-08-05 | butylidenephthalide | Everfront Biotech (Taiwan) | malignant glioma |
Granting of the orphan status in the US |
2015-08-19 | encapsulated spores from fecal microbiota | Seres Therapeutics (USA - MA) | recurrent Clostridium difficile infection (CDI) |
Granting of the orphan status in the US |
2015-09-04 | uridine triacetate | Wellstat Therapeutics (USA - Md) | hereditary orotic aciduria |
Granting of a Market Authorisation in the US |
2015-08-31 | udenafil | Mezzion Pharma (South Korea) | single ventricle congenital heart disease with Fontan physiology |
Granting of the orphan status in the US |
© 2024 Biopharmanalyses - Powered by Samacom+