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RSS FeedPosted by Michael Wonder on 14 Jun 2025
Xediton Pharmaceuticals announced today the Canadian approval and availability of Vabomere (meropenem-vaborbactam) in Canada
12 June 2025 - Xediton Pharmaceuticals is proud to announce that Vabomere (meropenem-vaborbactam) has been approved by Health Canada and ...
Posted by Michael Wonder on 11 Jun 2025
US FDA approves expanded indication for AbbVie's Mavyret (glecaprevir/pibrentasvir) as first and only treatment for people with acute hepatitis C virus
11 June 2025 - AbbVie today announced that the US FDA approved a label expansion for Mavyret (glecaprevir/pibrentasvir), an oral ...
Posted by Michael Wonder on 09 Jun 2025
George Medicines announces FDA approval of Widaplik (telmisartan, amlodipine and indapamide), a new single pill combination treatment for hypertension in adults, including initial treatment
9 June 2025 - Commercialisation planning underway with US launch anticipated Q4, 2025. ...
Posted by Michael Wonder on 12 May 2025
Trixeo Aerosphere approved in the UK as first inhaled respiratory medicine using next-generation propellant with near zero global warming potential
11 May 2025 - Trixeo Aerosphere, AstraZeneca’s fixed-dosed triple-combination therapy for COPD, is the Company’s first medicine to transition to ...
Posted by Michael Wonder on 28 Apr 2025
Vertex receives CHMP positive opinion for Alyftrek, a new once-daily CFTR modulator for the treatment of cystic fibrosis
28 April 2025 - In head-to-head clinical trials, deutivacaftor/tezacaftor/vanzacaftor was non-inferior on ppFEV1 and superior compared to Kaftrio (ivacaftor/tezacaftor/elexacaftor) at ...
Posted by Michael Wonder on 08 Apr 2025
European Commission approves expanded label for Kaftrio in combination with ivacaftor for people with cystic fibrosis
7 April 2025 - Approximately 4,000 people living with cystic fibrosis in the European Union are newly eligible for a ...
Posted by Michael Wonder on 08 Mar 2025
Vertex announces UK MHRA approval of Alyftrek (deutivacaftor/tezacaftor/vanzacaftor), a once daily next in class CFTR modulator for the treatment of cystic fibrosis
7 March 2025 - In head to head clinical trials, deutivacaftor/tezacaftor/vanzacaftor was non-inferior on ppFEV1 and further decreased sweat chloride ...
Posted by Michael Wonder on 03 Mar 2025
Vertex receives CHMP positive opinion for expanded label for Kaftrio in combination with ivacaftor for people with cystic fibrosis to include rare mutations
28 February 2025 - If approved, approximately 4,000 people with cystic fibrosis in the European Union will be eligible for ...
Posted by Michael Wonder on 07 Feb 2025
US FDA approves Emblaveo (aztreonam and avibactam) for the treatment of adults with complicated intra-abdominal infections with limited or no treatment options
7 February 2025 - Emblaveo is the first and only monobactam/β-lactamase inhibitor combination antibiotic therapy approved by the US FDA to ...
Posted by Michael Wonder on 31 Jan 2025
Axsome Therapeutics announces FDA approval of Symbravo (meloxicam and rizatriptan) for the acute treatment of migraine with or without aura in adults
30 January 2025 - A single oral dose of Symbravo provided rapid migraine pain freedom and return to normal functioning within ...
Posted by Michael Wonder on 22 Dec 2024
Vertex announces US FDA approval of Alyftrek, a once daily next in class CFTR modulator for the treatment of cystic fibrosis
20 December 2024 - In head to head clinical trials, Alyftrek was non-inferior on ppFEV1 and further decreased sweat chloride ...
Posted by Michael Wonder on 22 Dec 2024
Vertex announces US FDA approval for Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) to include additional non-F508del Trikafta responsive variants
20 December 2024 - Approximately 300 more people with cystic fibrosis in the US are now eligible for a medicine ...
Posted by Michael Wonder on 14 Dec 2024
Roche Canada and the pan-Canadian Pharmaceutical Alliance successfully complete negotiations for Tecentriq SC (atezolizumab solution for subcutaneous injection)
13 December 2024 - Roche Canada today announced that it successfully completed negotiations with the pan-Canadian Pharmaceutical Alliance for Tecentriq ...
Posted by Michael Wonder on 06 Dec 2024
Esperion announces new drug submissions in Canada for Nexletol (bempedoic acid) and Nexlizet (bempedoic acid and ezetimibe) treatments to reduce LDL-cholesterol and cardiovascular risk
2 December 2024 - Esperion today announced that it has filed new drug submissions to Health Canada for Nexletol and Nexlizet, ...
Posted by Michael Wonder on 18 Oct 2024
US FDA approves Vyalev (foscarbidopa and foslevodopa) for adults living with advanced Parkinson's disease
17 October 2024 - Adults treated with Vyalev reported superior improvement in "on" time without troublesome dyskinesia, compared to oral immediate-release ...