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Novo Nordisk files for EU approval of Ozempic in type II diabetes pharmatimes
April 28, 2019
Novo Nordisk has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for Ozempic (oral semaglutide), for the treatment of type II diabetes.
Amgen’s Blincyto gets EU approval for relapsed B cell precursor ALL pharmaceutical-technology
September 04, 2018
On June 19, Amgen announced that the European Commission (EC) has granted full approval for the bispecific antibody drug, Blincyto (blinatumomab), for patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymph
AstraZeneca’s Lokelma receives EU approval biospectrumasia
April 02, 2018
Lokelma is a highly-selective, oral potassium-removing agent. The approval is supported by data from three double-blind, placebo-controlled trials and one open-label trial, where patients with hyperkalaemia were treated for up to 12 months
AstraZeneca’s faslodex receives EU approval for advanced breast cancer treatment pharmaceutical-technology
July 31, 2017
The European Commission (EC) has approved AstraZeneca’s faslodex (fulvestrant) for the treatment of oestrogen-receptor positive, locally advanced or metastatic breast cancer in postmenopausal women not previously treated with endocrine therapy.
Debiopharm’s triptorelin 6-month formulation receives EU approval europeanpharmaceuticalreview
March 21, 2017
Debiopharm International received approval for the treatment of central precocious puberty (CPP) in 22 European countries.