Biogen cuts price for Alzheimer’s drug Aduhelm by half

20 December 2021 - The drug has sold poorly since its approval in June due to concerns about its safety, effectiveness ...

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Consultation paper on proposal to introduce a cost recovered pathway for Medical Services Advisory Committee applications

 4 January 2022 - The Department of Health invites submissions in relation to a proposal to introduce a cost recovered ...

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Will the Biden administration use ‘march-in’ to protect prostate cancer patients from excessive drug prices?

3 January 2022 - Astellas Pharma, a drug company headquartered in Japan, is charging U.S. patients $156,000 a year for ...

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Spero Therapeutics announces FDA acceptance and priority review of new drug application for tebipenem hydrobromide for the treatment of complicated urinary tract infections including pyelonephritis

3 January 2022 - The FDA has set a Prescription Drug User Fee Act target action date of 27 June 2022. ...

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Daratumumab in multiple myeloma: reassessment results in hint of considerable added benefit

3 January 2022 - Janssen applied for a new early benefit assessment due to new scientific findings.  ...

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Genprex receives U.S. FDA fast track designation for Reqorsa immunogene therapy in combination with Keytruda for the treatment of non-small-cell lung cancer

3 January 2022 - Second FDA fast track designation further validates the potential of Reqorsa. ...

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Novavax submits final data packages to U.S. FDA as prerequisite to Emergency Use Authorisation application request for COVID-19 Vaccine

30 December 2021 - EUA application request to be submitted following one month required by FDA EUA guidance. ...

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FDA grants ILiAD Biotechnologies fast track designation for next generation pertussis vaccine BPZE1

3 January 2021 - ILiAD Biotechnologies, today announced that the U.S. FDA has granted fast track designation to BPZE1, a next ...

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FDA takes multiple actions to expand use of Pfizer-BioNTech COVID-19 Vaccine

3 January 2021 - Today, the U.S. FDA amended the emergency use authorisation for the Pfizer-BioNTech COVID-19 Vaccine to: ...

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Paion submits extension application of marketing authorisation for remimazolam in the indication general anaesthesia to the European Medicines Agency

31 December 2021 - Paion today announces that it has submitted an extension application to the marketing authorisation for remimazolam ...

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Xeris Biopharma announces U.S. FDA approval of Recorlev (levoketoconazole) for the treatment of endogenous hypercortisolemia in adult patients with Cushing’s syndrome

30 December 2021 - FDA approval supported by positive results from the pivotal Phase 3 SONICS and LOGICS studies demonstrating Recorlev ...

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Schedule of Pharmaceutical Benefits - 1 January 2022 update

1 January 2022 - The January 2022 issue of the Schedule of Pharmaceutical Benefits is out and now in effect. ...

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New Zealand Pharmaceutical Schedule - 1 January 2022

1 January 2022 - The January 2022 issue of the New Zealand Pharmaceutical Schedule is now available and in effect. ...

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Celltrion acquires approval for its new Humira 'Yuflyma' in Canada

30 December 2021 - Celltrion announced on December 30 that it won marketing approval from Health Canada for "Yuflyma", a ...

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FDA accepts Arcutis Biotherapeutics’ new drug application for roflumilast cream for adults and adolescents with plaque psoriasis

22 December 2021 - FDA has set a target action date of 29 July 2022. ...

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Lexicon submits new drug application for sotagliflozin for the treatment of heart failure in adults with type 2 diabetes

30 December 2021 - ) -- Lexicon Pharmaceuticals today announced that it has submitted a new drug application to the U.S. ...

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