FDA clears first blood test used in diagnosing Alzheimer’s disease

16 May 2025 - New test provides less invasive option, reduces reliance on PET scans and increases diagnosis accessibility. ...

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PharmaTher announces FDA extends review period for ketamine; new approval goal date 9 August 2025

16 May 2025 -  PharmaTher today announced the US FDA has extended the approval goal date for the review of ...

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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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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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FDA fast tracks therapy for radiation-induced dry mouth

7 May 2025 - A therapy under development at the University of Wisconsin School of Medicine and Public Health to ...

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RegenxBio announces FDA acceptance and priority review of the BLA for RGX-121 for MPS II

13 May 2025 - FDA assigns PDUFA target action date of 9 November 2025. ...

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Trump says he will sign executive order on drug price caps

11 May 2025 - President Trump said Sunday he will sign an executive order Monday to cap prescription drug and ...

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