ICER to assess treatment for narcolepsy

17 October 2025 - Report will be subject of Midwest CEPAC meeting in May 2026; draft scoping document open to ...

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Libtayo (cemiplimab) recommended for EU approval by the CHMP for adjuvant treatment of cutaneous squamous cell carcinoma with a high risk of recurrence after surgery and radiation

17 October 2025 - Positive opinion based on results of Phase 3 C-POST trial that show Libtayo significantly reduced the ...

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Novartis Scemblix receives positive CHMP opinion for the treatment of adults with newly diagnosed CML

17 October 2025 - If approved, Scemblix will be indicated for adults with chronic myeloid leukaemia (CML), both newly diagnosed and ...

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Rare cancer lifeline comes with dual drug discounts

17 October 2025 - Two common immunotherapy drugs will now be subsidised for all advanced or metastatic cancers, providing a ...

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Immunotherapy for patients with advanced cancers

17 October 2025 - More Australians living with advanced cancer could have access to immunotherapy treatment options, thanks to a ...

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First HIV prevention injection for people unable to have daily PrEP recommended

17 October 2025 - A ground-breaking HIV-1 prevention injection has been recommended by NICE, marking a significant advance for a small ...

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Same time decisions on licensing and value - what pharmaceutical companies need to know

10 October 2025 - Learn how NICE and MHRA are launching an aligned pathway to accelerate patient access to medicines and ...

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Merck announces unprecedented agreement with US Government to expand access to IVF therapies

16 October 2025 - Merck announced today that EMD Serono, the healthcare business of Merck in the US and Canada, ...

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NovelWise Pharmaceutical receives FDA fast track designation for NBM-BMX in metastatic uveal melanoma

14 October 2025 - NovelWise Pharmaceutical today announced that the US FDA has granted fast track designation for NBM-BMX, a ...

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atai Life Sciences and Beckley Psytech announce US FDA breakthrough therapy designation granted to BPL-003, underscoring its potential in treatment-resistant depression

16 October 2025 - FDA designation follows previously announced Phase 2b topline data which showed rapid and durable anti-depressant outcomes following ...

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Recommendations made by the PBAC - September 2025

17 October 2025 - Recommendations made by the PBAC in September 2025 relating to the listing of medicines on the PBS ...

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FDA accepts Cingulate’s new drug application for CTx-1301 in attention deficit hyperactivity disorder and sets a 31 May 2026 PDUFA date

14 October 2025 - Cingulate today announced that the US FDA has accepted for review the new drug application for CTx-1301 ...

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PHARMAC cuts red tape to improve access to medicines for thousands of New Zealanders

16 October 2025 - PHARMAC is removing unnecessary renewal requirements for selected Special Authority medicines and products, making it easier ...

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Incyte Canada announces Health Canada approval of Opzelura (ruxolitinib) cream for the treatment of atopic dermatitis in children ages 2-11

15 October 2025 - First and only topical JAK inhibitor cream approved in Canada for paediatric atopic dermatitis. ...

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Corcept submits marketing authorisation application to EMA for relacorilant as a treatment for patients with platinum-resistant ovarian cancer

14 October 2025 - Corcept Therapeutics has submitted a marketing authorisation application to the EMA for relacorilant to treat patients ...

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