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RSS FeedPosted by Michael Wonder on 30 Mar 2021
Akebia submits new drug application to the FDA for vadadustat for the treatment of anaemia due to chronic kidney disease in adult patients on dialysis and not on dialysis
30 March 2021 - Akebia Therapeutics today announced that it has submitted a new drug application to the U.S. FDA ...
Posted by Michael Wonder on 30 Mar 2021
Germany to restrict AstraZeneca use in under-60s over clots
30 March 2021 - German health officials have agreed to restrict the use of AstraZeneca’s coronavirus vaccine in people under 60, ...
Posted by Michael Wonder on 30 Mar 2021
U.S. FDA accepts AbbVie's new drug application for atogepant for the preventive treatment of migraine
30 March 2021 - If approved, atogepant will be the first and only oral CGRP receptor antagonist specifically developed for the ...
Posted by Michael Wonder on 30 Mar 2021
Health Canada taking further action to confirm the benefit-risk profile of the AstraZeneca vaccine
29 March 2021 - As part of Health Canada’s continuing commitment to openness and transparency on all information relating to ...
Posted by Michael Wonder on 30 Mar 2021
Incyte announces the European Commission approval of Pemazyre (pemigatinib) as a treatment for adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 fusion or rearrangement
29 March 2021 - Pemazyre is the first targeted therapy approved in the European Union for this indication. ...
Posted by Michael Wonder on 30 Mar 2021
Karyopharm receives conditional marketing authorisation from the European Commission for Nexpovio (selinexor) in combination with dexamethasone for the treatment of adult patients with relapsed and or refractory multiple myeloma
29 March 2021 - Second European Regulatory Filing Based on Phase 3 BOSTON Data Expected by April 2021. ...
Posted by Michael Wonder on 30 Mar 2021
Canada urges halt in use of AstraZeneca COVID-19 vaccine in people under 55
30 March 2021 - Canadian authorities recommended Monday a halt on administering the AstraZeneca PLC COVID-19 vaccine on people under ...
Posted by Michael Wonder on 30 Mar 2021
Myovant Sciences announces European Medicines Agency validation of marketing authorisation application for relugolix for the treatment of advanced prostate cancer
29 March 2021 - Pfizer has an exclusive option to commercialise relugolix in oncology outside of the U.S. and Canada, ...
Posted by Michael Wonder on 29 Mar 2021
TG Therapeutics completes rolling submission of biologics license application to the U.S. FDA for ublituximab in combination with Ukoniq (umbralisib) as a treatment for patients with chronic lymphocytic leukaemia
29 March 2021 - TG Therapeutics today announced the completion of the rolling submission of a biologics license application to the ...
Posted by Michael Wonder on 29 Mar 2021
Merck receives complete response letter from US FDA for supplemental biologics license application for Keytruda (pembrolizumab) in high risk early stage triple negative breast cancer
29 March 2021 - Merck today announced that the U.S. FDA has issued a complete response letter regarding Merck’s supplemental biologics ...
Posted 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 29 Mar 2021
Rocket Pharmaceuticals receives EMA Priority Medicines (PRIME) designation for RP-L201 gene therapy for treatment of leukocyte adhesion deficiency-I
29 March 2021 - LAD-I program now holds all available accelerated regulatory designations in the U.S. and EU. ...
Posted by Michael Wonder on 29 Mar 2021
Mirum Pharmaceuticals announces FDA acceptance of new drug application and priority review for maralixibat in Alagille syndrome
29 March 2021 - PDUFA action date is 29 September 2021. ...
Posted by Michael Wonder on 29 Mar 2021
Saxenda recommended for approval by European Medicines Agency committee for the treatment of obesity in adolescents aged 12–17 years
26 March 2021 - Novo Nordisk today announced that the CHMP under the EMA has recommended that the use of Saxenda ...