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RSS FeedPosted 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 01 Oct 2025
New Zealand Pharmaceutical Schedule - 1 October 2025
1 October 2025 - The October 2025 issue of the New Zealand Pharmaceutical Schedule is now available and in effect. ...
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 15 Jul 2025
Vertex announces broad reimbursement agreement with NHS England for Alyftrek (deutivacaftor/tezacaftor/vanzacaftor) an innovative once daily CFTR modulator for the treatment of cystic fibrosis
14 July 2025 - All eligible people with cystic fibrosis in England can now benefit from this medicine - ...
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 24 Jun 2025
Australians with cystic fibrosis benefit from life changing expanded listing
24 June 2025 - More Australians living with cystic fibrosis will have affordable access to a life changing treatment option ...
Posted by Michael Wonder on 23 Jun 2025
‘Barriers lifted’: cystic fibrosis treatment reaches final waiting patients
23 June 2025 - Ex-Wallabies player Nathan Charles has lived with cystic fibrosis for decades. ...
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 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 ...