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RSS FeedPosted by Michael Wonder on 15 Oct 2021
Highlights from CHMP 11-14 October 2021 meeting
15 October 2021 - EMA’s CHMP recommended six medicines for approval at its October 2021 meeting. ...
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 14 Oct 2021
EMA starts rolling review of Evusheld (tixagevimab and cilgavimab)
14 October 2021 - EMA’s CHMP has started a rolling review of Evusheld (also known as AZD7442), a combination of ...
Posted by Michael Wonder on 13 Oct 2021
EU may consider deal on Merck's COVID pill after approval procedure begins
12 October 2021 - The European Union may consider signing a supply deal with U.S. drugmaker Merck for its experimental ...
Posted by Michael Wonder on 12 Oct 2021
EMA publishes agenda for 11-14 October CHMP meeting
11 October 2021 - The EMA has published a draft agenda for this week's CHMP meeting. ...
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 06 Oct 2021
Moderna announces European Medicines Agency authorises third dose of COVID-19 vaccine for immunocompromised individuals aged 12 years and older
5 October 2021 - Moderna today announced that the EMA has authorised a third dose of the Moderna COVID-19 vaccine (Spikevax) ...
Posted by Michael Wonder on 06 Oct 2021
EMA to consider rolling review for Merck's molnupiravir in coming days
5 October 2021 - The EMA will consider in the coming days whether to launch a rolling review of Merck's ...
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 ...
Posted by Michael Wonder on 02 Oct 2021
European Medicines Agency validates Bristol Myers Squibb’s application for LAG-3 blocking antibody relatlimab and nivolumab fixed dose combination as first-line treatment for patients with unresectable or metastatic melanoma
1 October 2021 - The Phase 2/3 RELATIVITY-047 trial served as the basis for this application, in which a statistically ...
Posted by Michael Wonder on 02 Oct 2021
European Medicines Agency validates Bristol Myers Squibb’s application for mavacamten for the treatment of obstructive hypertrophic cardiomyopathy
1 October 2021 - Application based on positive results from Phase 3 EXPLORER-HCM trial. ...
Posted by Michael Wonder on 01 Oct 2021
Xbrane Biopharma announces that partner Stada's marketing authorisation application for ranibizumab is submitted and validated by European Medicines Agency
30 September 2021 - Xbrane Biopharma today announces that a marketing authorisation Application for biosimilar ranibizumab submitted by its co-development ...