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EMA committee recommends 13 medicines for approval in January meeting europeanpharmaceuticalreview
February 02, 2021
The committee for human medicinal products recommended AstraZeneca’s COVID-19 vaccine be granted conditional marketing authorisation alongside 12 other approvals.
Chiesi Group Receives EMA for Triple-Combination Therapy Asthma americanpharmaceuticalreview
February 02, 2021
Chiesi announced the European Commission has granted the marketing authorization for Chiesi extrafine triple therapy combination ICS/LABA/LAMA in a single inhaler, for the treatment of asthma.
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.
EMA begins review of GBT's sickle cell treatment Oxbryta pharmatimes
January 29, 2021
The European Medicines Agency (EMA) has accepted a marketing authorisation application for Global Blood Therapeutic’s (GBT) Oxbryta (voxelotor).
Tessa Receives PRIME Designation from EMA for CD30 CAR-T Therapy americanpharmaceuticalreview
January 27, 2021
Tessa Therapeutics announced the European Medicines Agency (EMA) has granted PRiority MEdicines (PRIME) designation to the company's lead autologous CD30 CAR-T therapy for the treatment of relapsed or refractory classical Hodgkin Lymphoma (R/R cHL).
EMA receives authorisation application for AstraZeneca COVID-19 vaccine europeanpharmaceuticalreview
January 13, 2021
The EMA has received a conditional marketing authorisation application for the Oxford-AstraZeneca COVID-19 vaccine.
Moderna Covid-19 vaccine receives European Commission authorisation pharmaceutical-technology
January 08, 2021
The European Commission has granted a conditional marketing authorisation (CMA) to COVID-19 Vaccine Moderna for active immunisation to prevent the disease in individuals aged 18 years and above.
EMA launches review of BMS’ Opdivo for oesophageal cancer pharmatimes
January 06, 2021
The European Medicines Agency (EMA) has launched its centralized review process for Bristol Myers Squibb’s Opdivo (nivolumab) as an adjuvant treatment for oesophageal or gastroesophageal junction (GEJ) cancer.
Janssen files EGFR-targeting antibody amivantamab with EMA pharmatimes
January 05, 2021
Janssen, the pharmaceutical division of Johnson & Johnson, has submitted a marketing authorisation application to the European Medicines Agency (EMA) for approval of its epidermal growth factor receptor (EGFR)-targeting bispecific antibody amivantamab.
Amgen Submits Sotorasib Marketing Authorization Application to EMA americanpharmaceuticalreview
December 28, 2020
Amgen announced submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for sotorasib, an investigational KRASG12C inhibitor, for the treatment of adult patients with previously treated KRAS G12C-mutated ...

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