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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VBI Vaccines announces submission of biologics license application to FDA for 3 antigen prophylactic hepatitis B vaccine

1 December 2020 - VBI Vaccines today announced the submission of a biologics license application to the U.S. FDA seeking approval ...

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EMA starts rolling review of Janssen’s COVID-19 vaccine Ad26.COV2.S

1 December 2020 - EMA’s CHMP has started a rolling review of Ad26.COV2.S, a COVID-19 vaccine from Janssen-Cilag. ...

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Genentech announces FDA approval of Xolair (omalizumab) for adults with nasal polyps

1 December 2020 - Xolair is the first biologic for the treatment of nasal polyps that targets and blocks immunoglobulin E, ...

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Australia's 10 most commonly prescribed medicines revealed by PBS data

1 December 2020 - Australians continue to use statins more than any other prescription drug, with the two most common ...

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Outraged patients to present petition with over 30,000 signatures to ask for funding for desperately needed medication

2 December 2020 - Sick of waiting for years for PHARMAC to fund standard, current therapy to treat their diseases, ...

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FDA approves pralsetinib for RET altered thyroid cancers

1 December 2020 - Today the Food and Drug Administration approved pralsetinib (Gavreto, Blueprint Medicines) for adult and pediatric patients ...

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EMA receives application for conditional marketing authorisation of COVID-19 mRNA vaccine BNT162b2

1 December 2020 - EMA has received an application for conditional marketing authorisation for BNT162b2, a COVID‑19 mRNA vaccine developed by ...

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FDA approves first PSMA-targeted PET imaging drug for men with prostate cancer

1 December 2020 - Today, the U.S. FDA approved Gallium 68 PSMA-11 (Ga 68 PSMA-11) – the first drug for ...

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EMA receives application for conditional marketing authorisation of Moderna COVID-19 vaccine

1 December 2020 - EMA has received an application for conditional marketing authorisation for a COVID-19 mRNA vaccine by Moderna Biotech. ...

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Innovative technology to detect abnormal heart rhythms recommended by NICE for NHS use while further data is collected

1 December 2020 - Zio ZT is the first assessment, via the NICE digital health technologies guidance development pilot project, to ...

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Mirum Pharmaceuticals announces European Medicines Agency validation of the marketing authorisation application for maralixibat in patients with PFIC2

30 November 2020 - Five-year transplant-free survival data from the Phase 2 INDIGO study used as the basis for the MAA ...

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ARS announces acceptance of market authorisation application submission to European Medicines Agency for Neffy (ARS-1; epinephrine nasal spray)

30 November 2020 - ARS Pharmaceuticals announced today that the EMA has accepted a marketing authorisation application submission for review of ...

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Kadmon announces FDA acceptance of NDA for belumosudil in patients with chronic graft versus host disease

30 November 2020 - Application being evaluated Under FDA's Real-Time Oncology Review and Project Orbis pilot programs. ...

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ICER releases draft evidence report on therapies for anaemia in chronic kidney disease

30 November 2020 - Public comment period now open until 5 January 2021; requests to make oral comment during public meeting ...

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