FDA approves first faecal microbiota product

30 November 2022 - Today, the US FDA approved Rebyota, the first faecal microbiota product approved by the agency.  ...

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Blueprint Medicines submits supplemental new drug application to FDA for Ayvakit (avapritinib) for the treatment of indolent systemic mastocytosis

22 November 2022 - Blueprint Medicines today announced the submission of a supplemental new drug application to the US FDA for ...

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Agenda for the March 2023 PBAC meeting

23 November 2022 - The agenda for the March 2023 PBAC meeting is now available. ...

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Pacylex granted FDA fast track designation for PCLX-001 for the treatment of relapsed or refractory acute myeloid leukaemia

22 November 2022 - Pacylex today announced that the US FDA has granted PCLX-001 fast track designation for the treatment of ...

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FDA approves first gene therapy to treat adults with haemophilia B

22 November 2022 - Today, the US FDA approved Hemgenix (etranacogene dezaparvovec), an adeno-associated virus vector-based gene therapy for the treatment ...

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IntelGenx receives FDA PDUFA date for Rizafilm

22 November 2022 - IntelGenx today announced that the US FDA has accepted for review its Class 2 response to the ...

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Gamida Cell provides regulatory update on omidubicel

21 November 2022 - Recent company submission in response to FDA request extends PDUFA date by three months. ...

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Mark Cuban has taken on pharmacy benefit managers and forever disrupted healthcare in America

19 November 2022 - Imagine finding out that there is a drug on the market for your terminal disease.  ...

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UCB submits response to FDA complete response letter for bimekizumab

22 November 2022 - UCB today announced that it has resubmitted the biologics license application to the US FDA for ...

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GSK provides an update on Blenrep (belantamab mafodotin-blmf) US marketing authorisation

22 November 2022 - GSK today announced it has initiated the process for withdrawal of the US marketing authorisation for Blenrep ...

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Libtayo (cemiplimab) approved by the European Commission as the first immunotherapy in second-line recurrent or metastatic cervical cancer irrespective of PD-L1 expression level or tumour histology

22 November 2022 - Approval based on a Phase 3 trial that demonstrated significant survival benefit in patients with recurrent or ...

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Junshi Biosciences announces approval of supplemental application for additional indications of adalimumab injection

22 November 2022 - Shanghai Junshi Biosciences announced today that the supplemental application for additional indications of adalimumab injection (UBP1211) for ...

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argenx announces US FDA acceptance of biologics license application for subcutaneous efgartigimod in generalised myasthenia gravis with priority review

22  November 2022 - PDUFA target action date is 20 March 2023. ...

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NICE recommends Sobi’s Doptelet to treat thrombocytopenia

18 November 2022 - Primary ITP is a rare autoimmune condition characterised by high platelet destruction ...

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Carfilzomib in combination with daratumumab and dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma

22 November 2022 - NICE is unable to make a recommendation on the use of carfilzomib in combination with daratumumab and ...

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Tisagenlecleucel for the treatment of patients with follicular lymphoma after two or more therapies

22 November 2022 - NICE is unable to make a recommendation on the use of tisagenlecleucel for the treatment of adults ...

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