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EU approves expanded use of Janssen’s Spravato pharmatimes
February 09, 2021
The European Commission (EC) has approved the expanded use of Janssen’s Spravato for the rapid reduction of depressive symptoms in a psychiatric emergency, for adult patients with a moderate-to-severe episode of major depressive disorder (MDD).
EU approves Chiesi’s triple combination asthma therapy Trimbow pharmatimes
February 02, 2021
The European Commission (EC) has approved a marketing authorisation for Chiesi Group’s triple combination asthma therapy Trimbow (beclometasone/formoterol/glycopyrronium).
Novo Nordisk’s Sogroya moves closer towards EU approval pharmatimes
February 02, 2021
Novo Nordisk’s Sogroya (somapacitan) has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use – moving closer towards approval in the EU.
AstraZeneca to supply 9 million more vaccine doses: EU expresspharma
February 02, 2021
AstraZeneca has agreed to supply 9 million additional doses of its coronavirus vaccine to the European Union during the first quarter, the bloc’s executive arm said Sunday.
AstraZeneca COVID-19 Vaccine Recommended for use in the EU americanpharmaceuticalreview
February 01, 2021
AstraZeneca’s COVID-19 vaccine has been recommended for conditional marketing authorization (CMA) in the European Union (EU) for active immunization to prevent COVID-19 caused by SARS-CoV-2, in individuals 18 years of age and older.
AstraZeneca-Oxford COVID-19 vaccine approved in EU expresspharma
February 01, 2021
The AstraZeneca vaccine demonstrated efficacy of around 60 per cent in the trials on which the decision was based, the European Medicines Agency (EMA) said in a statement.
Mundipharma and Cidara’s rezafungin gets Orphan Drug Designation in EU pharmaceutical-technology
January 28, 2021
The European Commission (EC) has adopted the European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP) recommendation to grant Orphan Drug Designation (ODD) to Mundipharma and Cidara Therapeutics’ rezafungin for treating ...
AbbVie's Rinvoq bags two new EU approvals pharmatimes
January 27, 2021
The European Commission (EC) has approved AbbVie’s Rinvoq (upadacitinib) for the treatment of active psoriatic arthritis (PsA) and active ankylosing spondylitis (AS).
Keytruda scores new EU approval in colorectal cancer pharmatimes
January 27, 2021
MSD’s immunotherapy Keytruda (pembrolizumab) has been approved in the EU for the first-line treatment of metastatic Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) colorectal cancer.
Enhertu bags EU approval for HER2-positive breast cancer pharmatimes
January 21, 2021
AstraZeneca and Daiichi Sankyo’s HER2-targeting antibody drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) has been granted a conditional approval in the EU.

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