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RSS FeedPosted by Michael Wonder on 21 Jun 2021
Bayer submits regulatory applications for oncology treatment combination of copanlisib and rituximab in the U.S. and EU
21 June 2021 - Bayer today announced the submission of a supplemental new drug application to the U.S. FDA and a ...
Posted by Michael Wonder on 08 Jun 2021
Moderna files for conditional marketing approval for its COVID-19 vaccine in adolescents in the European Union
7 June 2021 - Submission based on Phase 2/3 study of mRNA-1273 in adolescents ages 12 to less than 18 ...
Posted by Michael Wonder on 30 May 2021
Calliditas announces submission of marketing authorisation application for Nefecon to the European Medicines Agency
28 May 2021 - Calliditas Therapeutics today announced that the company submitted a marketing authorisation application to the EMA for ...
Posted by Michael Wonder on 20 May 2021
EMA, MHRA to review Vertex' Kaftrio for children with cystic fibrosis
20 May 2021 - The EMA and the MHRA have validated Vertex' applications to expand the scope of its cystic ...
Posted by Michael Wonder on 07 May 2021
EMA starts rolling review of sotrovimab (VIR-7831) for COVID-19
7 May 2021 - EMA’s CHMP has started a ‘rolling review’ of data on sotrovimab (also known as VIR-7831 and ...
Posted by Michael Wonder on 04 May 2021
EMA starts rolling review of COVID-19 vaccine (Vero Cell) inactivated
4 May 2021 - EMA’s CHMP has started a rolling review of COVID-19 Vaccine (Vero Cell) inactivated, developed by Sinovac ...
Posted by Michael Wonder on 03 May 2021
EMA starts evaluating use of COVID-19 vaccine Comirnaty in young people aged 12 to 15
3 May 2021 - EMA has started evaluating an application to extend the use of the COVID-19 vaccine Comirnaty to ...
Posted by Michael Wonder on 01 May 2021
Legend Biotech announces submission of European marketing authorisation application for BCMA CAR-T therapy ciltacabtagene autoleucel (cilta-cel) for the treatment of relapsed and/or refractory multiple myeloma
30 April 2021 - Submission follows accelerated assessment granted by the Committee for Medicinal Products for Human Use of the European ...
Posted by Michael Wonder on 29 Apr 2021
EMA starts evaluating use of Olumiant in hospitalised COVID-19 patients requiring supplemental oxygen
29 April 2021 - EMA has started evaluating an application to extend the use of Olumiant (baricitinib) to include treatment ...
Posted by Michael Wonder on 28 Apr 2021
Y-mAbs submits omburtamab marketing authorisation application to the EMA
27 April 2021 - Y-mAbs Therapeutics today announced that the Company has submitted its marketing authorisation application to the European Medicines ...
Posted by Michael Wonder on 27 Apr 2021
EMA grants accelerated assessment procedure for Nefecon for the treatment of IgA nephropathy
23 April 2021 - Calliditas Therapeutics today announced that its lead product candidate Nefecon, a novel oral formulation targeting down regulation ...
Posted by Michael Wonder on 27 Apr 2021
Karyopharm announces European Medicines Agency's validation of its type II variation marketing authorisation application for Nexpovio (selinexor) in combination with Velcade (bortezomib) and dexamethasone for the treatment of adult patients with multiple myeloma
26 April 2021 - EMA regulatory decision expected in the fourth quarter of 2021. ...
Posted by Michael Wonder on 17 Apr 2021
Oncopeptides submits application for conditional marketing authorisation of melflufen in the EU
16 April 2021 - Oncopeptides today announces that the Company has submitted an application to the EMA for conditional marketing authorisation ...
Posted by Michael Wonder on 15 Apr 2021
EMA starts review of VIR-7831 for treating patients with COVID-19
15 April 2021 - EMA is reviewing currently available data on the use of the monoclonal antibody VIR-7831 (also known as ...
Posted by Michael Wonder on 07 Apr 2021
AbbVie submits regulatory applications for Skyrizi (risankizumab) in psoriatic arthritis to FDA and EMA
7 April 2021 - Submissions supported by two Phase 3 studies in patients with active psoriatic arthritis in which Skyrizi demonstrated ...