Blog
RSS FeedPosted by Michael Wonder on 15 Jul 2025
New cystic fibrosis drug fast tracked for NHS use
15 July 2025 - Some people with cystic fibrosis are set to benefit from a new once daily triple therapy treatment, ...
Posted by Michael Wonder on 03 Jul 2025
FDA grants accelerated approval to linvoseltamab-gcpt for relapsed or refractory multiple myeloma
2 July 2025 - Today the FDA granted accelerated approval to linvoseltamab-gcpt (Lynozyfic, Regeneron Pharmaceuticals), a bispecific B-cell maturation antigen ...
Posted by Michael Wonder on 02 Jul 2025
Calls for 'missing piece' menopause drug to be added to the PBS
2 July 2025 - A key treatment which could help around one million middle-aged Australian women remains unaffordable to many ...
Posted by Michael Wonder on 02 Jul 2025
Life-saving breast cancer drug now cheaper thanks to expansion of the PBS
1 July 2025 - A potentially life-saving treatment for early-stage breast cancer will become much more affordable for hundreds of ...
Posted by Michael Wonder on 02 Jul 2025
Adagrasib for adults with previously treated, advanced, KRAS G12C mutation positive non-small-cell lung cancer
2 July 2025 - NICE is unable to make a recommendation on the use of adagrasib (Krazati) for the second-line treatment ...
Posted by Michael Wonder on 01 Jul 2025
New Zealand Pharmaceutical Schedule - 1 July 2025
1 July 2025 - The July 2025 issue of the New Zealand Pharmaceutical Schedule is now available and in effect. ...
Posted by Michael Wonder on 01 Jul 2025
NICE welcomes the inclusion of measures for equal treatment of medicines and health technologies
1 July 2025 - The new approach will ensure that high impact devices, diagnostics and digital tools recommended by NICE, that ...
Posted by Michael Wonder on 01 Jul 2025
Schedule of Pharmaceutical Benefits - 1 July 2025
1 July 2025 - The July 2025 issue of the Schedule of Pharmaceutical Benefits is out and now in effect. ...
Posted by Michael Wonder on 01 Jul 2025
Unicycive Therapeutics announces receipt of complete response letter for oxylanthanum carbonate for the treatment of hyperphosphataemia in patients with chronic kidney disease on dialysis
30 June 2025 - No other concerns stated, including pre-clinical, clinical, or safety data. ...
Posted by Michael Wonder on 01 Jul 2025
Takeda announces US FDA approval of Gammagard Liquid ERC, the only ready to use liquid immunoglobulin therapy with low immunoglobulin A content
30 June 2025 - US commercialisation of Gammagard Liquid ERC projected to begin in 2026. ...
Posted by Michael Wonder on 30 Jun 2025
Minovia Therapeutics announces FDA fast track and rare paediatric disease designations for MNV-201 in Pearson syndrome
30 June 2025 - Minovia Therapeutics announces that the US FDA has granted fast track designation to the Company’s lead investigational ...
Posted by Michael Wonder on 29 Jun 2025
Pegzilarginase for the treatment of patients 2 years of age and older with arginase-1 deficiency
26 June 2025 - NICE has published additional draft guidance consultation on the use of pegzilarginase in the NHS in ...
Posted by Michael Wonder on 28 Jun 2025
Eylea 8 mg with extended 6 month treatment interval approved in the EU
27 June 2025 - The European Commission has granted a label extension in the EU for Eylea 8 mg (aflibercept 8 ...
Posted by Michael Wonder on 28 Jun 2025
Biocon Biologics receives Health Canada approval for Yesafili (aflibercept); first global launch scheduled for July 2025
27 June 2025 - Biocon Biologics is pleased to announce that Health Canada has granted a Notice of Compliance for Yesafili ...
Posted by Michael Wonder on 28 Jun 2025
Omeros submits narsoplimab marketing authorization application to the EMA for the treatment of TA-TMA
27 June 2025 - Omeros Corporation today announced the recent submission of a marketing authorisation application to the EMA for ...
Posted by Michael Wonder on 28 Jun 2025
FDA approves Gamifant (emapalumab-lzsg) as first-ever treatment for adults and children with Macrophage Activation Syndrome in Still's disease
28 June 2025 - Approval based on the pooled analysis of our pivotal EMERALD and NI-0501-06 studies, showing 54% of ...