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RSS FeedPosted by Michael Wonder on 01 Apr 2026
Vertex announces US FDA approval for label extensions of Alyftrek and Trikafta, expanding availability of these medicines to ~95% of all people with CF in the United States
1 April 2026 - Vertex Pharmaceuticals today announced the US FDA has approved expanded use of Alyftrek (vanzacaftor/tezacaftor/deutivacaftor) for the ...
Posted by Michael Wonder on 31 Mar 2026
European Commission approves Kygevi (doxecitine and doxribtimine) as first and only treatment for thymidine kinase 2 deficiency
31 March 2026 – UCB today announced that the European Commission has granted marketing authorisation under exceptional circumstances for Kygevi ...
Posted by Michael Wonder on 18 Dec 2025
Novo Nordisk files for FDA approval of CagriSema, the first onceweekly combination of GLP‑1 and amylin analogues for weight management
18 December 2025 - – Today, Novo Nordisk announced the submission of a new drug application to the US FDA ...
Posted by Michael Wonder on 02 Oct 2025
Wockhardt submits new drug application to US FDA for zidebactam-cefepime (WCK 5222) for treatment of serious gram-negative infections
1 October 2025 - Wockhardt today announced the submission of new drug application to the US FDA for its novel ...
Posted by Michael Wonder on 18 Aug 2025
Marketing authorisation application for CT001 has been submitted to the EMA for acute pain management in children
14 August 2025 - The marketing authorisation application for CT001 is submitted to the EMA for acute pain management in ...
Posted by Michael Wonder on 01 Aug 2025
US FDA approves new Biktarvy indication for people with HIV who are treatment experienced and restarting antiretroviral treatment
30 July 2025 - Gilead Sciences today announced that the US FDA has granted a new approval for a novel ...
Posted by Michael Wonder on 27 Jul 2025
Vertex announces marketing authorisation in Canada for Alyftrek, a once daily next generation CFTR modulator for the treatment of cystic fibrosis
22 July 2025 - Approximately 3,800 people in Canada are now eligible for Alyftrek, with up to 60 people potentially ...
Posted by Michael Wonder on 25 Jul 2025
Trixeo Aerosphere receives positive EU CHMP opinion as first inhaled medicine using next-generation propellant with near-zero Global Warming Potential
25 July 2025 - Next-generation propellant offers 99.9% reduction in global warming potential compared to current propellants. ...
Posted by Michael Wonder on 04 Jul 2025
Vertex Announces European Commission approval of Alyftek, a new once daily CFTR modulator for the treatment of cystic fibrosis
1 July 2025 - Approximately 31,000 people with cystic fibrosis in the EU are now eligible for this new highly ...
Posted 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 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 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 ...