Blenrep (belantamab mafodotin) combinations approved in Canada for the treatment of relapsed/refractory multiple myeloma

23 July 2025 - Superior efficacy shown in two head-to-head phase III trials, including overall survival in DREAMM-7. ...

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Clearside Biomedical announces approval of Xipere suprachoroidal treatment for uveitic macular oedema in Canada

23 July 2025 - Clearside Biomedical announced today that Health Canada has granted approval for Xipere (triamcinolone acetonide injectable suspension) ...

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Anzupgo (delgocitinib) cream is now the first and only FDA approved treatment for moderate to severe chronic hand eczema in adults

23 July 2025 - In Phase 3 clinical trials, patients experienced significant skin clearance along with marked relief from pain and ...

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European Commission approves Imbruvica (ibrutinib) as the first targeted therapy for patients with previously untreated mantle cell lymphoma who would be eligible for autologous stem cell transplant

23 July 2025 - Data from the Phase 3 TRIANGLE study defines the fixed-duration ibrutinib-based regimen as a new standard of ...

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European Commission approves Roche’s Itovebi for people with ER positive, HER2 negative, advanced breast cancer with a PIK3CA mutation

23 July 2025 - Approval based on INAVO120 data showing the Itovebi (inavolisib)-based regimen more than doubled progression-free survival compared with ...

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Replimune receives complete response letter from FDA for RP1 biologics license application for the treatment of advanced melanoma

23 July 2025 - Replimune Group today announced that the US FDA has issued a complete response letter regarding the ...

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Health Canada approves Keytruda for the treatment of adult patients with FIGO 2014 Stage III-IVA cervical cancer, in combination with chemoradiotherapy

21 July 2025 - Approval is based on the results from Phase 3 KEYNOTE-A18/ENGOT-cx11/GOG-30472 ...

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Bayer’s Nubeqa (darolutamide) receives EU approval in third indication for patients with advanced prostate cancer

21 July 2025 - Approval is based on positive results from the pivotal Phase 3 ARANOTE trial and reinforces darolutamide’s established ...

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Thousands could benefit from first immunotherapy for severe birch tree pollen allergy

21 July 2025 - We have recommended the first under the tongue tablet immunotherapy shown to build long-term tolerance to allergens, ...

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MHRA approves adrenaline nasal spray - the first needle-free emergency treatment for anaphylaxis in the UK

18 July 2025 - The MHRA has today approved adrenaline nasal spray (EURneffy) to be used for the emergency treatment of ...

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European Commission grants conditional approval of Ezmekly

18 July 2025 - Ezmekly is the first and only therapy to receive marketing authorisation in the EU for both adults ...

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Genentech provides update on supplemental biologics license application for Columvi combination for people with relapsed or refractory diffuse large B-cell lymphoma

18 July 2025 - Genentech announced today that the US FDA issued a complete response letter for Genentech’s supplemental biologics ...

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US FDA approves GSK’s Shingrix in a pre-filled syringe presentation

17 July 2025 - Pre-filled syringe presentation offers a convenient administration option to health care professionals. ...

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SMC - July 2025 decisions

7 July 2025 - The SMC which advises on newly licensed medicines for use by NHSScotland, has today published advice ...

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MHRA approves sebetralstat (Ekterly) to treat hereditary angioedema attacks in patients aged 12 and over

15 July 2025 - The MHRA has today approved sebetralstat (Ekterly) for the treatment of hereditary angioedema attacks in adults and ...

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