Date | Compound | Laboratory | Indication | Type of Information |
---|---|---|---|---|
2016-01-22 | onabotulinumtoxinA | Allergan (Ireland) | lower limb spasticity |
Granting of a Market Authorisation in the US |
2015-03-16 | Horizon Discovery (UK) | Product launch | ||
2016-06-21 | calcifediol - vitamin D prohormone | Opko Health (USA - Fl) | prevention and treatment of secondary hyperparathyroidism (SHPT) in patients with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency |
Granting of a Market Authorisation in the US |
2015-08-18 | flibanserin | Sprout Pharmaceuticals (USA - NC) | acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women |
Granting of a Market Authorisation in the US |
2017-03-28 | solithromycin | Cempra (USA - NC) | community acquired bacterial pneumonia (CABP) | Withdrawal of a market application in the EU |
2015-11-23 | hydroxyprogesterone caproate injection | Amag Pharmaceuticals (USA - MA) | reduction of the risk of preterm birth in women who are pregnant with one baby and who have spontaneously delivered one preterm baby in the past |
Refusal of a Market Authorisation in the US |
2018-03-05 | prucalopride | Shire (UK - USA) |
|
Acceptation for review of a NDA |
2016-02-15 | necitumumab | Eli Lilly (USA -IN) | advanced squamous non-small cell lung cancer (NSCLC) |
Granting of a Market Authorisation in the EU |
2018-09-20 | venetoclax | Genentech, a member of Roche Group (USA - CA - Switzerland) AbbVie (USA -IL) | chronic lymphocytic leukaemia (CLL) | Positive opinion for the granting of a Market Authorisation in the EU |
2015-08-24 | stem cells storage services | Cellaviva (Sweden) | Product launch | |
2015-03-11 | Herceptin® (trastuzumab) monitoring test | Theradiag (France) | metastatic breast cancer metastatic gastric cancer | Granting of a Market Authorisation in the EU |
2016-06-23 | ofatumumab | Novartis (Switzerland) | maintenance therapy of patients with relapsed chronic lymphocytic leukemia (CLL) extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive chronic lymphocytic leukemia (CLL) |
Negative opinion for the granting of a Market Authorisation in the EU |
2015-06-01 | idelalisib and ofatumumab | Gilead Sciences (USA - CA) | previously-treated patients with chronic lymphocytic leukemia (CLL) |
Submission of an sNDA |
2016-02-10 | combination comprising rifabutin, clarithromycin, and clofazamine | Redhill Biopharma (Israel) | Crohn’s Disease |
Granting of a patent |
2015-05-12 | evofosfamide | Merck Serono, a Merck KGaA company (Germany) | advanced pancreatic cancer |
Granting of a Fast Track status |
2017-02-07 | etelcalcetide | Amgen (USA - CA) | secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) on hemodialysis | Granting of a Market Authorisation in the US |
2015-07-10 | delmopinol | Merial (France) | reduction of plaque, calculus and halitosis |
Product launch |
2015-06-04 | olipudase alfa | Genzyme (USA - MA), a Sanofi company (France) | Niemann-Pick Disease type B |
Granting of the Breakthrough Therapy status |
2015-09-03 | Cytoo (France) | Product launch | ||
2015-08-27 | empagliflozin plus immediate-release metformin hydrochloride fixed-dose combination | Boehringer Ingelheim (Germany) Eli Lilly (USA - IN) | type 2 diabetes | Granting of a Market Authorisation in the US |
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