Amneal receives US FDA approval for Brekiya (dihydroergotamine mesylate) injection for the acute treatment of migraine and cluster headaches in adults

15 May 2025 - Product will be available for appropriate patients in the second half of 2025 ...

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ICER publishes final evidence report on treatment for retinitis pigmentosa

15 May 2025 - Independent appraisal committee voted that current evidence is adequate to demonstrate a net health benefit of ...

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FDA approves retifanlimab-dlwr with carboplatin and paclitaxel and as a single agent for squamous cell carcinoma of the anal canal

15 May 2025 - Today, the FDA approved retifanlimab-dlwr (Zynyz, Incyte) with carboplatin and paclitaxel for the first-line treatment of ...

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Deal agreed for continued access to life-changing treatment for rare inherited disease

14 May 2025 - NICE is consulting on draft guidance for cerliponase alfa for treating neuronal ceroid lipofuscinosis type 2, ...

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FDA grants accelerated approval to telisotuzumab vedotin-tllv for non-small cell lung cancer with high c-Met protein overexpression

14 May 2025 - Today, the FDA granted accelerated approval to telisotuzumab vedotin-tllv (Emrelis, AbbVie), a c-Met-directed antibody and microtubule ...

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FDA approves belzutifan for pheochromocytoma or paraganglioma

14 May 2025 - Today, the FDA approved belzutifan (Welireg, Merck) for adult and paediatric patients 12 years and older ...

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MHRA approves first UK treatment for congenital thrombotic thrombocytopenic purpura

12 May 2025 - The MHRA has today approved rADAMTS13 (Adzynma), the first UK treatment to treat congenital thrombotic thrombocytopenic purpura ...

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SMC - May 2025 decisions

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

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Osimertinib mesylate in combination with pemetrexed disodium heptahydrate and platinum-based chemotherapy for patients with advanced EGFR mutation positive non-small-cell lung cancer (final guidance)

8 May 2025 - Osimertinib mesylate, when used in combination with pemetrexed disodium heptahydrate and platinum-based chemotherapy, is recommended as an ...

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Itulatek approved for treatment of children and adolescents in Canada

8 May 2025 - ALK today announced that Health Canada has approved ALK’s regulatory filing for Itulatek (tree pollen sublingual allergy ...

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FDA grants accelerated approval to the combination of avutometinib and defactinib for KRAS-mutated recurrent low-grade serous ovarian cancer

8 May 2025 - Today, the FDA granted accelerated approval to the combination of avutometinib and defactinib (Avmapki Fakzynja Co-pack, ...

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Brentuximab vedotin in combination with chemotherapy for the treatment of patients with stage 3 or 4 CD30 positive Hodgkin lymphoma

7 May 2025 - Brentuximab vedotin, when used in combination with doxorubicin hydrochloride, dacarbazine and vinblastine sulphate is recommended as an ...

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MHRA approves teprotumumab as the first UK treatment for adults with moderate to severe thyroid eye disease

7 May 2025 - The MHRA has today approved teprotumumab (Tepezza).  ...

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European Commission approves Tremfya (guselkumab), the first dual-acting IL-23 inhibitor offering both subcutaneous and intravenous induction options, for adult patients with moderately to severely active Crohn's disease

7 May 2025 - Data from the pooled GALAXI 2 and 3 studies showed that guselkumab demonstrated greater efficacy compared to ...

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Omaveloxolone for the treatment of patients with Friedreich’s ataxia

6 May 2025 - NICE is unable to make a recommendation on the use of omaveloxolone (Skyclarys) for the treatment of ...

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