FDA approval of Leqembi subcutaneous formulation charts path to combination therapies for Alzheimer's disease

29 August 2025 - Subcutaneous delivery increases accessibility and introduces potential for at home administration, following model of diabetes and ...

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US FDA grants full approval of Vitrakvi (larotrectinib) for adult and paediatric patients with NTRK gene fusion-positive solid tumours

10 April 2025 - The full approval of Vitrakvi is based on the results of confirmatory trials that support Vitrakvi as ...

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argenx announces FDA approval of Vyvgart Hytrulo pre-filled syringe for self-injection in generalised myasthenia gravis and chronic inflammatory demyelinating polyneuropathy

10 April 2025 - Self-injection provides generalised myasthenia gravis and chronic inflammatory demyelinating polyneuropathy patients with flexibility for when and where to receive ...

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Health Canada approves Imfinzi (durvalumab) as the first and only immunotherapy regimen for adult patients with limited-stage small cell lung cancer

10 April 2025 - Health Canada has granted a Notice of Compliance for Imfinzi (durvalumab), as monotherapy, for the treatment ...

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Biocon Biologics announces US FDA approval for Jobevne, biosimilar bevacizumab

10 April 2025 - Biocon Biologics today announced that the US FDA has approved Jobevne (bevacizumab-nwgd), a biosimilar bevacizumab for ...

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13,000 people to benefit from new insulin medicine

11 April 2025 - Pharmac will fund a new type of insulin for people with diabetes, branded as Ryzodeg, from ...

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Trastuzumab deruxtecan approved to treat adults with HER2-positive cancer that has spread or cannot be removed by surgery

9 April 2025 - The MHRA has today approved trastuzumab deruxtecan (Enhertu) to treat people with solid tumours that have ...

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Arcturus Therapeutics receives US FDA fast track designation for the STARR mRNA vaccine candidate ARCT-2304 for pandemic influenza A virus H5N1

10 April 2025 - Arcturus Therapeutics today announced that the US FDA has granted fast track designation for the self-amplifying mRNA ...

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Pfizer wins Korea nod for paediatric arthritis use of oral JAK inhibitor Xeljanz

7 April 2025 - Pfizer Korea has won national reimbursement for its oral JAK inhibitor Xeljanz (tofacitinib), expanding access to ...

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Hundreds of people in England to benefit from take-at-home tablet bladder cancer treatment

10 April 2025 - Today, for the first time, we have given the green light to a targeted treatment for the ...

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Lorlatinib for the treatment of patients with advanced ALK positive non-small-cell lung cancer (review of TA909)

9 April 2025 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...

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PHARMAC to fund medicines for blood cancers, inflammatory bowel disease, eczema and arthritis

10 April 2025 - More New Zealanders will have access to medicines for blood cancers, bowel diseases, eczema and arthritis, ...

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ICER releases obesity medications white paper examining strategies to ensure affordable access

9 April 2025 - Paper analyses policy reforms and market actions to achieve affordable and equitable access for GLP-1 obesity ...

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Outlook Therapeutics announces acceptance of biologics license application by US FDA for ONS-5010 as a treatment for wet AMD

8 April 2025 - PDUFA goal date of 27 August 2025. ...

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Xspray Pharma re-submits its FDA application

8 April 2024 - Xspray Pharma has re-submitted its application for market approval for Dasynoc, the company's lead product candidate, an ...

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Tenpoint Therapeutics submits new drug application to US FDA for Brimichol PF for the treatment of presbyopia

8 April 2025 - NDA submission includes efficacy and safety data for the first fixed-dose combination therapy from the world’s ...

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