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RSS FeedPosted by Michael Wonder on 01 Dec 2022
FDA approves first faecal microbiota product
30 November 2022 - Today, the US FDA approved Rebyota, the first faecal microbiota product approved by the agency. ...
Posted by Michael Wonder on 23 Nov 2022
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 ...
Posted by Michael Wonder on 23 Nov 2022
Agenda for the March 2023 PBAC meeting
23 November 2022 - The agenda for the March 2023 PBAC meeting is now available. ...
Posted by Michael Wonder on 23 Nov 2022
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 ...
Posted by Michael Wonder on 23 Nov 2022
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 ...
Posted by Michael Wonder on 22 Nov 2022
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 ...
Posted by Michael Wonder on 22 Nov 2022
Gamida Cell provides regulatory update on omidubicel
21 November 2022 - Recent company submission in response to FDA request extends PDUFA date by three months. ...
Posted by Michael Wonder on 22 Nov 2022
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. ...
Posted by Michael Wonder on 22 Nov 2022
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 ...
Posted by Michael Wonder on 22 Nov 2022
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 ...
Posted by Michael Wonder on 22 Nov 2022
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 ...
Posted by Michael Wonder on 22 Nov 2022
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 ...
Posted by Michael Wonder on 22 Nov 2022
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. ...
Posted by Michael Wonder on 22 Nov 2022
NICE recommends Sobi’s Doptelet to treat thrombocytopenia
18 November 2022 - Primary ITP is a rare autoimmune condition characterised by high platelet destruction ...
Posted by Michael Wonder on 22 Nov 2022
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 ...
Posted by Michael Wonder on 22 Nov 2022
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 ...