Neurelis announces FDA approval for immediate use seizure medication Valtoco (diazepam nasal spray) in age 2 to 5

16 April 2025 - Valtoco maintains orphan drug exclusivity for Valtoco to treat episodes of frequent seizures. ...

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Scilex announces approval of a new drug submission from the Health Canada for Elyxyb’s acute treatment of migraine with or without aura in Canada

15 April 2025 - Elyxyb is a first-line treatment and the only FDA approved, ready to use oral solution for the ...

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Leqembi (lecanemab) is the first medicine that slows progression of early Alzheimer’s disease to be authorised in the European Union

15 Apil 2025 - Eisai and Biogen announced today that the European Commission has granted the amyloid-beta monoclonal antibody Leqembi (lecanemab) ...

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US FDA grants interchangeable designation to Yuflyma (adalimumab-aaty), Celltrion's biosimilar to Humira (adalimumab)

14 April 2025 - Interchangeable designation of Yuflyma is supported by positive data from the Phase 3 interchangeability study in ...

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Health Canada approves Nduvra (tapinarof 1% cream) for the topical treatment of plaque psoriasis in adults

14 April 2025 - Organon today announced that Health Canada has approved Nduvra (tapinarof cream), 1%, the first in a novel ...

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European Commission approves Roche’s Columvi as the first bispecific antibody for diffuse large B-cell lymphoma after initial therapy

14 April 2025 - Approval based on Phase 3 STARGLO study where Columvi in combination with chemotherapy showed a 41% reduction ...

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Thousands of people a year could benefit from new twice a day tablet for advanced breast cancer

11 April 2025 - We've published final draft guidance recommending capivasertib with fulvestrant, which means the treatment will be funded immediately ...

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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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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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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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FDA approves nivolumab with ipilimumab for unresectable or metastatic MSI-H or dMMR colorectal cancer

8 April 2025 - Today, the FDA approved nivolumab (Opdivo, Bristol Myers Squibb Company) with ipilimumab (Yervoy, Bristol Myers Squibb ...

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Datroway approved in the EU for patients with previously treated metastatic HR positive, HER2 negative breast cancer

8 April 2025 - Second DXd antibody drug conjugate approved in EU based on Daiichi Sankyo’s DXd technology ...

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