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, ...

Read more →

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 ...

Read more →

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 ...

Read more →

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. ...

Read more →

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 ...

Read more →

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. ...

Read more →

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. ...

Read more →

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. ...

Read more →

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 ...

Read more →

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26 June 2025 - NICE has published additional draft guidance consultation on the use of pegzilarginase in the NHS in ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

Ultragenyx receives breakthrough therapy designation for GTX-102 in Angelman syndrome

27 June 2025 - Phase 3 Aspire study enrollment on track to complete in 2025. ...

Read more →

Schrödinger receives fast track designation for SGR-1505 for the treatment of relapsed/refractory Waldenström's macroglobulinemia

27 June 2025 - Demonstrates the potential of SGR-1505 as a novel approach for diseases with high unmet medical need. ...

Read more →