Healyth Canada authorised Lilly's Kisunla (donanemab), a new treatment for early Alzheimer's disease

4 May 2026 - Today, after more than 35 years of commitment to advancing Alzheimer's research, Lilly Canada announced Health Canada's ...

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Norgine welcomes TGA registration in Australia of Pedmarqsi (sodium thiosulphate anhydrous) for the prevention of cisplatin-induced hearing loss in children

6 May 2026 - Norgine is pleased to announce that Pedmarqsi (sodium thiosulphate anhydrous) has been registered by the Australian TGA ...

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New first in class therapy for chronic graft versus host disease approved in Australia

3 May 2026 -  Specialised Therapeutics is pleased to announce that Niktimvo (axatilimab) has been approved for use in Australia ...

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Apotex becomes the first Canadian‑based pharmaceutical company to receive Health Canada approval for a generic equivalent of Ozempic

1 May 2026 - Apotex today announced that Health Canada has approved Apo‑Semaglutide Injection, a generic equivalent of Ozempic (semaglutide injection).  ...

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Novartis receives Health Canada approval for Fabhalta oral treatment for adults with C3G

1 May 2026 - Novartis Pharmaceuticals Canada announced today that Health Canada has granted a Notice of Compliance for Fabhalta (iptacopan ...

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Incyte announces FDA Approval of Jakafi XR (ruxolitinib) extended release tablets for the treatment of myelofibrosis, polycythemia vera and graft versus host disease

1 May 2026 - Jakafi XR will be available for pharmacy orders by 8 May 2026. ...

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MHRA approves Linerixibat (Lynavoy) for the treatment of itch due to biliary tract disease

1 May 2026 - The MHRA has today  approved Linerixibat (Lynavoy) for use to treat an itch in adults with primary biliary cholangitis. ...

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Stelara paediatric Crohn’s disease FDA approval J&J statement

1 May 2026 - On 15 April 2026, the US FDA approved Stelara (ustekinumab) for the treatment of patients two ...

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Arrowhead Pharmaceuticals receives TGA approval of Redemplo (plozasiran) in Australia, expanding global access for patients with familial chylomicronaemia syndrome

1 May 2026 - The approval in Australia is based on positive results from the Phase 3 PALISADE study where ...

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FDA approves vepdegestrant for ER positive, HER2 negative, ESR1 mutated advanced or metastatic breast cancer

1 May 2026 - Today, the FDA approved vepdegestrant (Veppanu, Arvinas), a heterobifunctional protein degrader, for adults with oestrogen receptor ...

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FDA approves first non-antipsychotic drug to treat agitation associated with dementia

30 April 2026 - The US FDA today approved an expanded use for Auvelity (dextromethorphan hydrobromide and bupropion hydrochloride) extended-release tablets ...

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First NICE recommended treatment for uncontrolled generalised myasthenia gravis

29 April 2026 -  We’ve recommended a new treatment called rozanolixizumab for some adults living with generalised myasthenia gravis whose ...

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European Commission approves Henlius and Organon's Poherdy (pertuzumab), the first approved biosimilar to Perjeta (pertuzumab) in Europe

29 April 2026 - Shanghai Henlius Biotech, and Organon today announced the European Commission has granted marketing authorization for Poherdy (pertuzumab) ...

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Richter receives European Commission approval for Tuyory, its biosimilar tocilizumab in multiple indications

29 April 2026 - Gedeon Richter announces today that the European Commission granted marketing authorisation for Tuyory, its biosimilar to ...

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Norgine announces European Commission marketing authorisation for Xolremdi (mavorixafor), the first authorised treatment for patients with WHIM syndrome in the European Union

29 April 2026 - Norgine today announced that the European Commission has granted marketing authorisation for mavorixafor as Xolremdi following a ...

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