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RSS FeedPosted by Michael Wonder on 02 Nov 2021
EMA ends rolling review of the antibodies bamlanivimab and etesevimab for COVID-19 following withdrawal by Lilly
2 November 2021 - EMA has ended the rolling review of bamlanivimab and etesevimab, two antibodies for the treatment of ...
Posted by Michael Wonder on 29 Oct 2021
Incyte announces the validation of the European marketing authorisation application for ruxolitinib cream in vitiligo
28 October 2021 - The marketing authorisation application seeks approval of ruxolitinib cream for the treatment of adolescent and adult patients ...
Posted by Michael Wonder on 29 Oct 2021
Reata Pharmaceuticals submits marketing authorisation application to the EMA for bardoxolone methyl in chronic kidney disease caused by Alport syndrome
28 October 2021 - Reata Pharmaceuticals today announced its submission of a marketing authorisation application for bardoxolone methyl to the ...
Posted by Michael Wonder on 27 Oct 2021
Novartis receives priority review by US FDA and filing acceptance by EMA for Kymriah to treat patients with relapsed or refractory follicular lymphoma
27 October 2021 - Filings supported by pivotal ELARA trial, where treatment with Kymriah showed robust response rates and remarkable safety ...
Posted by Michael Wonder on 26 Oct 2021
Lilly pipeline success strengthens future growth potential
27 October 2021 - Lilly announces today its U.S. submission of tirzepatide in type 2 diabetes using a priority review ...
Posted by Michael Wonder on 25 Oct 2021
Merck and Ridgeback announce initiation of a rolling review by the European Medicines Agency for molnupiravir, an investigational oral anti-viral medicine, for the treatment of COVID-19 in adults
25 October 2021 - If granted marketing authorisation by the European Commission, molnupiravir could be the first oral anti-viral medicine for ...
Posted by Michael Wonder on 25 Oct 2021
COVID-19: EMA starts rolling review of molnupiravir
25 October 2021 - EMA’s CHMP has started a rolling review of the oral antiviral medicine molnupiravir (MK 4482; Lagevrio), ...
Posted by Michael Wonder on 24 Oct 2021
EU decision on Russia's Sputnik V shot 'impossible' this year
21 October 2021 - The EU drug regulator is unlikely to decide whether to approve Russia's Sputnik V coronavirus vaccine until ...
Posted by Michael Wonder on 18 Oct 2021
EMA starts evaluating use of COVID-19 vaccine Comirnaty in children aged 5 to 11
18 October 2021 - EMA has started evaluating an application to extend the use of BioNTech/Pfizer’s COVID-19 vaccine, Comirnaty, to ...
Posted by Michael Wonder on 14 Oct 2021
Rhythm Pharmaceuticals completes submission of type II variation application to the European Medicines Agency for Imcivree (setmelanotide) for Bardet-Biedl and Alström syndromes
14 October 2021 - Rhythm Pharmaceuticals today announced that it has submitted its type II variation application to the EMA for ...
Posted by Michael Wonder on 14 Oct 2021
Celltrion applies for product approval for Avastin biosimilar in EU
12 October 2021 - Celltrion said that it has completed the approval application procedure for CT-P16, a biosimilar of Avastin ...
Posted by Michael Wonder on 12 Oct 2021
EMA ends rolling review of CVnCoV COVID-19 vaccine following withdrawal by CureVac
13 October 2021 - The EMA has ended the rolling review of CVnCoV, CureVac AG’s COVID-19 vaccine, after the company ...
Posted by Michael Wonder on 11 Oct 2021
EMA receives application for marketing authorisation for Ronapreve (casirivimab with imdevimab) for treatment and prevention of COVID-19
11 October 2021 - EMA has started evaluating an application for marketing authorisation for the monoclonal antibody combination Ronapreve (casirivimab ...
Posted by Michael Wonder on 05 Oct 2021
Comirnaty and Spikevax: EMA recommendations on extra doses and boosters
4 October 2021 - EMA’s CHMP has concluded that an extra dose of the COVID-19 vaccines Comirnaty (BioNTech/Pfizer) and Spikevax ...
Posted by Michael Wonder on 05 Oct 2021
EMA receives application for marketing authorisation for Regkirona (regdanvimab) for treating patients with COVID-19
4 October 2021 - EMA has started evaluating an application for marketing authorisation for the monoclonal antibody Regkirona (regdanvimab, also known ...