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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Hyposensitisation with AR101 in peanut allergy: proof of lesser benefit

17 January 2022 - In the patient-relevant outcomes, there are only disadvantages for 4- to 17-year-olds compared to a pure peanut-avoiding ...

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Swissmedic grants temporary authorisation to Xevudy for COVID-19 patients

14 January 2022 - Corona medication Xevudy from GSK (sotrovimab) granted temporary authorisation in Switzerland ...

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Serb receives EU approval for Voraxaze (glucarpidase) as rescue therapy for high dose methotrexate toxicity

14 January 2022 -  Serb and BTG Specialty Pharmaceuticals today announced that the European Commission has granted marketing authorisation for ...

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Keytruda reimbursement boosts MSD’s R&D of follow-up drug

17 January 2022 - The government’s recognition of MSD’s Keytruda (pembrolizumab) for reimbursement as the first-line therapy for lung cancer ...

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TGA approves ‘game changing’ ovarian cancer drug bringing new hope to patients

18 January 2022 - Federal health authorities have approved a breakthrough drug for ovarian cancer, bringing a game-changing treatment option ...

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$421,000 cancer drug Kymriah becomes eligible for reimbursement

14 January 2022 - Novartis’ breakthrough cancer treatment Kymriah (ingredient: tisagenlecleucel), which costs over 500 million won (US$421,000), has become ...

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SMC - January 2022 decisions

17 January 2022 - Advice on four new medicines for use in conditions including advanced breast cancer and non-small cell ...

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TGA recognises the Gamaleya Institute vaccine (Sputnik V, Russian Federation) for international travel to Australia

17 January 2022 - Today, the TGA determined that an additional COVID-19 vaccine, the two dose course of the Gamaleya ...

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Enhertu granted priority review in the U.S. for patients with HER2 positive metastatic breast cancer treated with a prior anti-HER2 based regimen

17 January 2022 - Application being evaluated under FDA Real-Time Oncology Review and Project Orbis ...

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ATAGI update following weekly COVID-19 meeting (12 January 2022)

17 January 2022 - Previously, severely immunocompromised people aged 12 years and older were recommended to receive a third primary dose ...

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PHARMAC - 2021 in review

17 January 2022 - PHARMAC released its Year in Review for 2021 in late December. ...

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Basilea announces approval of antifungal Cresemba (isavuconazole) for invasive aspergillosis in China

13 January 2022 - Second approved indication after invasive mucormycosis in December 2021. ...

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Ascendis Pharma receives European Approval for TransCon hGH for paediatric growth hormone deficiency

13 January 2022 - TransCon hGH (approved by the European Commission as Lonapegsomatropin Ascendis Pharma) is a once-weekly prodrug of somatropin ...

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COVID-19 vaccine weekly safety report (13 January 2022)

13 January 2022 - To 9 January 2022, the TGA has received 952 reports which have been assessed as likely to ...

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COVID-19 vaccine weekly safety report (6 January 2022)

17 January 2022 - To 2 January 2022, the TGA has received 415 reports which have been assessed as likely to ...

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