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RSS FeedPosted by Michael Wonder on 16 Feb 2021
EMA receives application for conditional marketing authorisation of COVID-19 Vaccine Janssen
16 February 2021 - EMA has received an application for conditional marketing authorisation for a COVID-19 vaccine developed by Janssen-Cilag. ...
Posted by Michael Wonder on 12 Feb 2021
EMA starts rolling review of CureVac’s COVID-19 vaccine (CVnCoV)
12 February 2021 - EMA’s human medicines committee (CHMP) has started a rolling review of CVnCoV, a COVID‑19 vaccine being ...
Posted by Michael Wonder on 10 Feb 2021
Clarification on Sputnik V vaccine in the EU approval process
10 February 2021 - The EMA has to date not received an application for a rolling review or a marketing ...
Posted by Michael Wonder on 07 Feb 2021
Novavax announces start of rolling review by multiple regulatory authorities for COVID-19 vaccine authorisation
4 February 2021 - Rolling reviews have commenced by FDA, MHRA, EMA and Health Canada. ...
Posted by Michael Wonder on 04 Feb 2021
EMA reviewing data on monoclonal antibody use for COVID-19
4 February 2021 - EMA’s CHMP is reviewing available data on the use of the monoclonal antibodies casirivimab, imdevimab, bamlanivimab and ...
Posted by Michael Wonder on 04 Feb 2021
EMA starts rolling review of Novavax’s COVID-19 vaccine (NVX-CoV2373)
3 February 2021 - EMA’s CHMP has started a rolling review of NVX-CoV2373, a COVID‑19 vaccine being developed by Novavax. ...
Posted by Michael Wonder on 02 Feb 2021
Janssen announces CAR-T therapy ciltacabtagene autoleucel (cilta-cel) accepted for accelerated assessment in Europe for the treatment of patients with heavily pretreated multiple myeloma
1 February 2021 - Janssen announced today that the CHMP of the EMA will perform an accelerated assessment of the ...
Posted by Michael Wonder on 01 Feb 2021
EMA starts rolling review of REGN-COV2 antibody combination (casirivimab/imdevimab)
1 February 2021 - EMA’s human medicines committee (CHMP) has started a ‘rolling review’ of data on a medicine known ...
Posted by Michael Wonder on 27 Jan 2021
European Medicines Agency accepts GBT’s marketing authorisation application for Oxbryta (voxelotor) for the treatment of haemolytic anemia in sickle cell disease
27 January 2021 - Global Blood Therapeutics today announced that the EMA has completed the validation of GBT’s marketing authorisation application ...
Posted by Michael Wonder on 14 Jan 2021
Johnson & Johnson could apply for EMA approval in February
14 January 2021 - US pharmaceutical company Johnson & Johnson may submit an official application for approval of its COVID-19 ...
Posted by Michael Wonder on 12 Jan 2021
EMA receives application for conditional marketing authorisation of COVID-19 Vaccine AstraZeneca
12 January 2020 - EMA has received an application for conditional marketing authorisation (CMA) for a COVID-19 vaccine developed by AstraZeneca ...
Posted by Michael Wonder on 12 Jan 2021
ObsEva provides update on Yselty (linzagolix) clinical development program
11 January 2021 - European Medicines Agency validates Yselty marketing authorisation application for uterine fibroids; US NDA Planned for 1H 2021. ...
Posted by Michael Wonder on 05 Jan 2021
European Medicines Agency validates Bristol Myers Squibb’s application for Opdivo (nivolumab) combined with chemotherapy as first-line treatment in metastatic gastric cancer, gastro-oesophageal junction cancer and oesophageal adenocarcinoma
4 January 2021 - Bristol Myers Squibb today announced that the EMA validated its Type II Variation marketing authorisation application ...
Posted by Michael Wonder on 05 Jan 2021
European Medicines Agency validates Bristol Myers Squibb’s application for Opdivo (nivolumab) as adjuvant treatment for resected oesophageal or gastro-oesophageal junction cancer following chemoradiotherapy
4 January 2021 - Bristol Myers Squibb today announced that the EMA validated its marketing authorisation application for Opdivo (nivolumab) ...
Posted by Michael Wonder on 30 Dec 2020
Update on rolling review of AstraZeneca’s COVID-19 vaccine
30 December 2020 - EMA’s assessment of the COVID-19 vaccine being developed by AstraZeneca and Oxford University has been progressing ...