Date | Compound | Laboratory | Indication | Type of Information |
---|---|---|---|---|
2017-08-23 | odiparcil | Inventiva Pharma (France) | mucopolysaccharidosis type VI (Maroteaux-Lamy syndrome) | Granting of the orphan status in the EU |
2017-08-29 | Daiichi Sankyo (Japan) | HER2-positive, locally advanced or metastatic breast cancer who have been treated with trastuzumab and pertuzumab and have disease progression after ado-trastuzumab emtansine (T-DM1) | Granting of the Breakthrough Therapy status | |
2018-09-20 | meropenem-vaborbactam | Rempex Pharmaceuticals (USA - CA) Melinta Therapeutics (USA - CT) | complicated urinary tract infections (cUTI), including a type of kidney infection, pyelonephritis, ca used by specific bacteria | Positive opinion for the granting of a Market Authorisation in the EU |
2017-09-01 | gemtuzumab ozogamicin | Pfizer (USA - NY) |
|
Granting of a Market Authorisation in the US |
2017-08-30 | tocilizumab | Roche (Switzerland) | CAR T Cell therapy-induced cytokine release syndrome | Granting of a Market Authorisation in the US |
2017-07-20 | tocilizumab | Roche (Switzerland) | giant cell arteritis | Positive opinion for the granting of a Market Authorisation in the EU |
2017-08-16 | R-Azasetron besylate | Sensorion (France) | prevention of platinum-induced ototoxicity in pediatric patients | Granting of the orphan status in the US |
2017-06-13 | tanezumab | Eli Lilly (USA -IN) Pfizer (US - NY) |
|
Granting of a Fast Track status |
2017-10-16 | Glucopyranosyl lipid A stable emulsion | Immune Design (USA - MA) | follicular non-Hodgkin's lymphoma | Granting of the orphan status in the EU |
2018-01-25 | ertugliflozin monotherapy, ertugliflozin and Januvia® (sitagliptin), fixed-dose combination of ertugliflozin and metformin. | Merck&Co (USA - NJ) Pfizer (USA - NY) | type 2 diabetes | Positive opinion for the granting of a Market Authorisation in the EU |
2017-03-14 | pembrolizumab | Merck&Co (USA - NJ) | advanced microsatellite instability-high (MSI-H) cancer | Submission of an sNDA |
2017-02-13 | signal-interfering DNA (siDNA) product | Onxeo (France) | Granting of a patent | |
2017-09-05 | pembrolizumab | Merck&Co (USA - NJ) | locally advanced or metastatic urothelial carcinoma (bladder cancer) | Granting of a Market Authorisation in the EU |
2017-09-15 | brivaracetam | UCB (Belgium) | partial-onset (focal) seizures in patients 16 years and older with epilepsy | Granting of a Market Authorisation in the US |
2017-02-22 | synthetic hypericin | Soligenix (USA - NJ) | psoriasis | Granting of a patent |
2017-09-18 | fluticasone furoate/umeclidinium/vilanterol | GSK (UK) | maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting ?2-agonist | Granting of a Market Authorisation in the US |
2015-11-18 | naloxone hydrochloride | Adapt Pharma (USA - PA) | opioid overdose | Granting of a Market Authorisation in the US |
2017-11-10 | buprenorphine and naloxone sublingual tablet | Mundipharma (UK) Orexo (Sweden) | opioid dependence | Granting of a Market Authorisation in the EU |
2017-09-14 | naloxone | Mundipharma (UK) | opioid overdose | Positive opinion for the granting of a Market Authorisation in the EU |
2017-05-15 | Diamyd Medical (Sweden) | Granting of a patent |
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