Anti-viral drug should not be first choice in treating COVID-19

3 December 2022 - The most widely prescribed anti-viral drug in Australia, molnupiravir, should no longer be routinely given for ...

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PHARMAC seeking feedback on funding Trikafta

4 December 2022 - PHARMAC has reached a provisional agreement with medicine supplier Vertex to fund Trikafta. ...

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Anti-viral COVID-19 treatment now available in the Netherlands for 1,250 Euros

1 December 2022 - The anti-viral medication approved to treat COVID-19 is now available on the Dutch market, the Dutch Association ...

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Statistical approaches to establishing bioequivalence

2 December 2022 - Requirements for submitting bioavailability and bioequivalence data in investigational new drugs, new drug applications, abbreviated new drug ...

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EMA validates application for arpraziquantel to treat schistosomiasis in pre-school aged children

2 December 2022 - Merck, a leading science and technology company, and the Pediatric Praziquantel Consortium, today announced that the EMA ...

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Brexucabtagene autoleucel for the treatment of adults with relapsed or refractory B-cell acute lymphoblastic leukaemia

2 December 2022 - The Department of Health and Social Care has asked NICE to produce guidance on the use of ...

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Orchard Therapeutics announces Swissmedic validation of the marketing authorisation application for Libmeldy (atidarsagene autotemcel)

1 December 2022 - Orchard Therapeutics today announced its marketing authorisation application for Libmeldy (atidarsagene autotemcel) has been accepted for ...

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European Medicines Agency accepts marketing authorisation application for momelotinib for the treatment of myelofibrosis

2 December 2022 - Application includes data from key Phase 3 trials, including the pivotal MOMENTUM trial, which met all ...

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AbbVie announces provincial reimbursement for Rinvoq (upadacitinib) for the treatment of rheumatoid arthritis and psoriatic arthritis in Alberta, New Brunswick, Ontario, Quebec and Saskatchewan

1 December 2022 - AbbVie today announced that Rinvoq is now listed as a special authorisation medication or exception medication status ...

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Hopes $55k breast cancer drug Keytruda will get PBS listing

3 December 2022 - Women with triple negative breast cancer have been given new hope that immunotherapy drug Keytruda will ...

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EQRx announces acceptance of marketing authorisation application by the European Medicines Agency for aumolertinib in EGFR mutated non-small-cell lung cancer

2 December 2022 - Application is based on data from the pivotal Phase 3 AENEAS trial evaluating aumolertinib as first-line ...

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COVID-19 vaccine safety report (1 December 2022)

1 December 2022 - To 27 November 2022, the TGA has received 709 reports which have been assessed as likely to ...

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FDA approves olutasidenib for relapsed or refractory acute myeloid leukaemia with a susceptible IDH1 mutation

1 December 2022 - Today, the FDA approved olutasidenib (Rezlidhia) capsules for adult patients with relapsed or refractory acute myeloid ...

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Tezepelumab for the treatment of patients with severe asthma

2 December 2022 - The Department of Health and Social Care has asked NICE to produce guidance on the use of ...

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Y-mAbs announces complete response letter for omburtamab biologics license application

1 December 2022 - Y-mAbs Therapeutics today announced that the US FDA has issued a complete response letter for the ...

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