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RSS FeedPosted 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 ...
Posted by Michael Wonder on 29 Mar 2021
GSK receives CHMP positive opinion recommending approval of Benlysta for adult patients with active lupus nephritis
26 March 2021 - GlaxoSmithKline today announced the CHMP of the EMA has adopted a positive opinion recommending the use of ...
Posted by Michael Wonder on 29 Mar 2021
Vertex receives CHMP positive opinion for Kaftrio (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor to treat people with cystic fibrosis with at least one F508del mutation
26 March 2021 - If approved, people ages 12 years and older who have one copy of the F508del mutation and ...
Posted by Michael Wonder on 29 Mar 2021
Amazon gets emergency FDA approval for at-home COVID-19 test kit
26 March 2021 - Amazon on Friday received emergency use authorisation from the FDA for an at-home COVID-19 testing kit that ...
Posted by Michael Wonder on 29 Mar 2021
Mezzion announces resubmission of new drug application for its orphan drug udenafil to treat patients who have undergone the Fontan operation for single ventricle heart disease
28 March 2021 - Submitted for FDA priority review as a rare paediatric disease product application. ...
Posted by Michael Wonder on 29 Mar 2021
Building a more robust medicine supply - proposals to help prevent, mitigate and manage medicine shortages
29 March 2021 - The Therapeutic Goods Administration is conducting a public consultation seeking feedback on reforms intended to help ...
Posted by Michael Wonder on 28 Mar 2021
Astellas receives positive CHMP opinion for Xtandi (enzalutamide) for patients with metastatic hormone-sensitive prostate cancer
26 March 2021 - If approved by the European Commission, enzalutamide will be the only oral therapy for the treatment of ...
Posted by Michael Wonder on 27 Mar 2021
FDA approves first cell-based gene therapy for adult patients with multiple myeloma
27 March 2021 - The U.S. FDA approved Abecma (idecabtagene vicleucel), a cell-based gene therapy to treat adult patients with multiple ...
Posted by Michael Wonder on 26 Mar 2021
Highlights from the CHMP 22-25 March 2022 meeting
26 March 2021 - EMA’s CHMP recommended five medicines for approval at its March 2021 meeting. ...