US hopeful of pre-Christmas COVID jab, Australia still has long wait

1 December 2020 - Millions of vulnerable Americans could be vaccinated against coronavirus before the end of 2020 but it ...

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COVID-19 shots could reach first Americans by mid-December, top health official says

23 November 2020 - U.S. health care workers and others recommended for the nation’s first COVID-19 inoculations could start getting shots ...

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Theralase granted FDA fast track designation for NMIBC Phase 2 clinical study

23 November 2020 - Theralase Technologies announced today that the U.S. FDA has granted Theralase fast track designation for its ...

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AB201 development as a potential treatment for COVID-19 receives U.S. FDA fast track designation

23 November 2020 - AB201 is the only novel compound being developed for COVID associated coagulopathy. ...

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Kiniksa announces U.S. FDA acceptance of sBLA and priority review for rilonacept in recurrent pericarditis

23 November 2020 - Filing based on positive data from RHAPSODY, which achieved its primary and all major secondary endpoints. ...

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Catalent signs commercial supply agreement with Blueprint Medicines following FDA approval of Gavreto (pralsetinib)

23 November 2020 - Catalent today announced that it had entered into a commercial supply agreement with Blueprint Medicines following FDA ...

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FDA expands approval of influenza treatment to post-exposure prevention

23 November 2020 - Today, the U.S. FDA expanded the approved indication for Xofluza (baloxavir marboxil) to include post-exposure prevention of ...

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BeiGene announces the approval of Xgeva (denosumab) in China for the prevention of skeletal-related events in patients with bone metastases from solid tumours and in patients with multiple myeloma

19 November 2020 - BeiGene today announced that the China NMPA has approved Xgeva (denosumab) for the prevention of skeletal-related events ...

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argenx enters into agreement to acquire priority review voucher

23 November 2020 - argenx today announced that the company has agreed to acquire a U.S. FDA priority review voucher from ...

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European Commission approves MenQuadfi, the latest innovation in meningococcal vaccination for individuals 12 months of age and older

23 November 2020 - EC approval based on robust data from seven pivotal Phase 2 and 3 trials involving more than ...

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Woman trying to raise $110,000 a month for life-extending breast cancer treatment

23 November 2020 - “Pay up or die” is the choice for a woman in her 30s trying to raise ...

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Politics, science and the remarkable race for a coronavirus vaccine

21 November 2020 - The furious race to develop a coronavirus vaccine played out against a presidential election, between a pharmaceutical ...

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Alexion receives marketing authorisation from European Commission for new formulation of Ultomiris (ravulizumab) with significantly reduced infusion time

20 November 2020 - The new 100 mg/mL formulation will reduce infusion time by approximately 60%, lessening the burden on patients. ...

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Ethinyloestradiol 20 mcg with desogestrel 150 mcg and 7 inert tablets (Mercilon 28)

23 November 2020 - Ethinyloestradiol 20 mcg with desogestrel 150 mcg and 7 inert tablets (Mercilon 28) will be fully funded ...

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Funding changes to dornase alfa for cystic fibrosis

23 November 2020 - From 1 December 2020 dornase alfa will be listed in the Community and the Hospital Medicines List ...

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Stage 2 PBS process improvements and revised cost recovery arrangements - information forum

23 November 2020 - The Department of Health will host a webinar on 7 December 2020, to launch Stage 2 ...

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