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CHMP Grants Positive Opinion for New Indication of Rubraca americanpharmaceuticalreview
December 17, 2018
Clovis Oncology announced the European Union’s (EU) European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending.....
European approval for Takeda's Alunbrig in ALK+ advanced non-small cell lung cancer pharmafile
November 29, 2018
Takeda’s Alunbrig (brigatinib) has been granted marketing approval by the European Commission as a monotherapy to treat anaplastic lymphoma kinase-positive (ALK+) advanced non-small
European approval for Takeda's Alunbrig in ALK+ advanced non-small cell lung cancer pharmafile
November 28, 2018
Takeda’s Alunbrig (brigatinib) has been granted marketing approval by the European Commission as a monotherapy to treat anaplastic lymphoma kinase-positive (ALK+) advanced non-small...
Novartis' gene therapy Luxturna becomes first approved European therapy for vision loss subtype pharmafile
November 26, 2018
Novartis has revealed that its one-time gene therapy Luxturna (voretigene neparvovec) has been awarded approval by the European Commission to be marketed...
First-ever all-oral drug for sleeping sickness recommended for approval by EMA committee pharmafile
November 21, 2018
Sanofi’s fexinidazole, the first all-oral therapy for the treatment of human African trypanosomiasis (HAT), or sleeping sickness, has secured a positive opinion from the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHM
Amgen Receives CHMP Positive Opinion to Expand Use of Blincyto americanpharmaceuticalreview
November 20, 2018
Amgen announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has ado
EU suspends GVK Bio medicine for non-compliance biospectrumasia
October 23, 2018
EU suspends GVK Bio medicine for non-compliance
Takeda gets positive CHMP opinion for ALUNBRIG biospectrumasia
September 29, 2018
As part of this submission, the CHMP also reviewed data from the first interim analysis of the Phase 3 ALTA-1L trial, which met its primary endpoint...
Janssen Receives Positive CHMP Opinion to Expand Invokana, Vokanamet americanpharmaceuticalreview
August 03, 2018
Janssen announced that the Committee for Medicinal Products for Human Use (CHMP), of the European Medicines Agency (EMA)......
Keytruda-chemotherapy combination gets CHMP nod pharmatimes
July 31, 2018
MSD’s Keytruda may become the first anti-PD-1 drug in Europe to be approved in combination with chemotherapy, following a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP).

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