FDA approval of Leqembi subcutaneous formulation charts path to combination therapies for Alzheimer's disease

29 August 2025 - Subcutaneous delivery increases accessibility and introduces potential for at home administration, following model of diabetes and ...

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Calico Life Sciences announces US FDA fast track designation for investigational treatment of autosomal dominant polycystic kidney disease

2 October 2025 - Calico Life Sciences today announced the US FDA granted fast track designation for ABBV-CLS-628, an investigational therapy ...

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PHARMAC proposes changes to make it easier to access HIV medicines

1 October 2025 - New Zealanders living with, or at risk of, HIV could soon benefit from proposed changes to ...

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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 ...

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TAHO Pharma announces submission of new drug application to the US FDA for TAH3311 – the world’s first apixaban oral dissolving film – represents a transformational advancement in anti-coagulant therapy

30 September 2025 - TAHO Pharmaceuticals today announced the submission of its new drug application to the US FDA for TAH3311, ...

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Pharming Group announces US FDA acceptance and priority review of supplemental new drug application for leniolisib in children with APDS aged 4 to 11 years

1 October 2025 - Pharming today announced that the US FDA has accepted its supplemental new drug application seeking approval for ...

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Organon Canada announces the availability of Nduvra (1% tapinarof cream) for the topical treatment of plaque psoriasis in adults

1 October 2025 - Organon Canada announces the availability of Ndruvra (1% tapinarof cream) for the topical treatment of plaque psoriasis ...

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Sentynl Therapeutics updates on its NDA for CUTX-101

1 October 2025 - Sentynl Therapeutics announced today that the US FDA has issued a complete response letter relating to ...

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Bristol Myers Squibb’s anti-MTBR-tau targeting antibody, BMS-986446, granted fast track designation by US FDA for the treatment of Alzheimer’s disease

1 October 2025 - Anti-microtubule binding region-tau antibody being investigated as a potential disease-modifying therapy to slow or delay progression of ...

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Enhertu followed by THP supplemental biologics license application accepted in the US for patients with high risk HER2 positive early stage breast cancer prior to surgery

1 October 2025 - Based on results from DESTINY-Breast11, the first Phase 3 trial to demonstrate benefit of Daiichi Sankyo ...

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White House unveils ‘TrumpRx’ drug buying site and a Pfizer pricing deal

30 September 2025 - The company says it gains a three year grace period to exempt it from national-security-related tariffs. ...

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Imfinzi’s bid for coverage faces Keytruda’s double-edged impact in Korea

30 September 2025 - AstraZeneca's immuno-oncology drug Imfinzi (durvalumab) is attempting to expand its reimbursement coverage, but its competitor, MSD's ...

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Public prostate cancer patients told treatment provided by public hospitals no longer available

1 October 2025 - Men with aggressive prostate cancer who were being treated with a groundbreaking drug have been told ...

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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. ...

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Disc Medicine announces submission of new drug application to US FDA for accelerated approval of bitopertin for patients with erythropoietic protoporphyria

30 September 2025 - Disc is seeking accelerated approval and priority review of its new drug application submission. ...

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Novo Nordisk resubmits Awiqli to the FDA with potential to be the first once weekly basal insulin treatment for adults with type 2 diabetes

29 September 2025 - Awiqli (insulin icodec) injection, if approved, has the potential to be the first once weekly basal insulin ...

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