Bayer files for approval of finerenone in heart failure in the EU

3 February 2025 - Regulatory submission is based on positive data from the Phase 3 FINEARTS-HF study presented at ESC Congress ...

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BMS receives European Commission approval for peri-operative regimen of neo-adjuvant Opdivo (nivolumab) and chemotherapy followed by adjuvant Opdivo for resectable, high risk non-small cell lung cancer with PD-L1 expression ≥1%

16 May 2025 - Approval based on results from the CheckMate-77T trial which showed perioperative Opdivo improved event-free survival compared ...

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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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Kaerus Bioscience's lead candidate KER-0193 granted orphan drug designation and rare paediatric drug designation by US FDA for treatment of Fragile X syndrome

14 May 2025 - Kaerus Bioscience today announces that its lead candidate KER-0193 has been granted both orphan drug designation and ...

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FDA grants regenerative medicine advanced therapy designation for BrainChild Bio’s B7-H3 CAR T-cell therapy for incurable paediatric brain tumours

15 May 2025 - BrainChild Bio advancing BCB-276 towards BLA submission with a single pivotal Phase 2 trial planned to ...

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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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FDA sets PDUFA-date for Xspray Pharma’s re-submitted application for Dasynoc

14 May 2025 - The US FDA has acknowledged receipt of Xspray Pharma's re-submitted new drug application) for Dasynoc.  ...

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FDA extends PDUFA date of Biohaven's troriluzole NDA for rare disease spinocerebellar ataxia

14 May 2025 - Troriluzole would be the first and only FDA approved treatment for spinocerebellar ataxia, if approved. ...

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BioCryst announces FDA acceptance of NDA for Orladeyo (berotralstat) oral granules in patients with hereditary angioedema aged 2 to 11 years

14 May 2025 - FDA grants priority review of application, with PDUFA target action date of 12 September 2025. ...

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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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Health inequalities - an update to NICE’s methods for health technology evaluation

14 May 2025 - Our new modular update focuses on how we consider health inequalities when evaluating technologies for use in ...

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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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Lilly Canada announces availability of Mounjaro KwikPen (tirzepatide) in all doses, advancing care for adults living with type 2 diabetes

13 May 2025 - The multi-dose, single-patient-use, pre-filled pen allows for personalised treatment plans that can cater to individual patient ...

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