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RSS FeedPosted by Michael Wonder on 29 Mar 2021
Amryt announces validation of its MAA by the EMA for Oleogel-S10 (Filsuvez)
29 March 2021 - Amryt today announces the validation of the Company’s marketing authorisation application for Oleogel-S10 by the EMA for ...
Posted by Michael Wonder on 29 Mar 2021
European Medicines Agency validates Bristol Myers Squibb’s application for Opdivo (nivolumab) as adjuvant treatment for patients with muscle-invasive urothelial carcinoma
29 March 2021 - If approved, Opdivo would be the first adjuvant immunotherapy option for patients with muscle-invasive urothelial carcinoma in ...
Posted by Michael Wonder on 26 Mar 2021
European Medicines Agency accepts marketing authorisation application for enfortumab vedotin
26 March 2021 - Enfortumab vedotin to be reviewed under accelerated assessment for the treatment of locally advanced or metastatic urothelial ...
Posted by Michael Wonder on 26 Mar 2021
Takeda begins regulatory submissions for dengue vaccine candidate in EU and Dengue-endemic countries
26 March 2021 - EMA to conduct first-ever parallel assessment of a medicinal product, Takeda’s dengue vaccine candidate (TAK-003), for use ...
Posted by Michael Wonder on 11 Mar 2021
EMA starts rolling review of Eli Lilly antibodies bamlanivimab and etesemivab for COVID-19
11 March 2021 - EMA’s CHMP has started a ‘rolling review’ of data on the antibodies bamlanivimab and etesemivab which are ...
Posted by Michael Wonder on 09 Mar 2021
Sesen Bio submits marketing authorisation application to the European Medicines Agency for Vicineum
8 March 2021 - Potential approval in Europe anticipated in early 2022. ...
Posted by Michael Wonder on 05 Mar 2021
Idorsia submits European marketing authorisation application for daridorexant for the treatment of adult patients with insomnia
3 March 2021 - The application includes robust data from the Phase 3 registration program, which demonstrated efficacy of daridorexant ...
Posted by Michael Wonder on 04 Mar 2021
Blueprint Medicines announces EMA validation of type II variation marketing authorisation application for Ayvakyt (avapritinib) for the treatment of advanced systemic mastocytosis
3 March 2021 - Blueprint Medicines today announced that the EMA has validated the company's type II variation marketing authorisation application ...
Posted by Michael Wonder on 04 Mar 2021
EMA starts rolling review of the Sputnik V COVID-19 vaccine
4 March 2021 - EMA’s CHMP has started a rolling review of Sputnik V (Gam-COVID-Vac), a COVID-19 vaccine developed by Russia’s ...
Posted by Michael Wonder on 01 Mar 2021
LFB announces that the EMA has accepted for filing the marketing authorisation application for eptacog beta (activated), a recombinant coagulation factor VIIa
1 March 2021 - In addition, LFB announces the online publication of the exploratory in vitro study results on eptacog beta ...
Posted by Michael Wonder on 01 Mar 2021
Incyte announces the validation by the European Medicines Agency of its marketing authorisation application for retifanlimab as a treatment for patients with squamous cell anal carcinoma
26 February 2021 - Incyte today announced the validation of the Company’s marketing authorisation application for retifanlimab, an intravenous PD-1 ...
Posted by Michael Wonder on 01 Mar 2021
EMA accepts Pfizer's marketing authorisation application for its investigational 20 valent pneumococcal conjugate vaccine for adults 18 years of age or older
26 February 2021 - If approved, the vaccine would help protect adults against 20 serotypes responsible for the majority of invasive ...
Posted by Michael Wonder on 28 Feb 2021
EMA accepts marketing application for somatrogon to treat paediatric patients with growth hormone deficiency
26 February 2021 - If approved, somatrogon will serve as a once-weekly treatment option. ...
Posted by Michael Wonder on 24 Feb 2021
EMA starts rolling review of Celltrion antibody regdanvimab for COVID-19
24 February 2021 - EMA’s CHMP has started a ‘rolling review’ of data on the monoclonal antibody regdanvimab (also known ...
Posted by Michael Wonder on 20 Feb 2021
Confusion over Russia's EU vaccine approval bid could be result of misdirected application
20 February 2021 - Russia’s submission of its Sputnik V vaccine for approval by the European Union’s medicines regulator appears ...