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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Outcome in relation to discussion of COVID-19 oral treatments – November 2022 PBAC meeting

24 November 2022 - A PBAC outcome in relation to discussion of COVID-19 oral treatments at the November 2022 meeting has ...

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Luspatercept for the treatment of patients with anaemia caused by myelodysplastic syndrome

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

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Luspatercept for the treatment of patients with anaemia caused by beta thalassaemia

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

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Korea to add Canada, Australia to drug pricing reference country list

24 November 2022 - The Government said it would additionally reference Canada and Australia when setting drug prices from January ...

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Rezvoglar becomes second interchangeable insulin biosimilar

23 November 2022 - The FDA has granted Eli Lilly’s long-acting insulin glargine biosimilar, Rezvoglar, an interchangeability designation, making it ...

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ICER to assess gene therapies for sickle cell disease

23 November 2022 - Report will be subject of CTAF meeting in June 2023; draft scoping document open to public ...

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InnoCare announces approval of Hibruka (orelabrutinib) for the treatment of mantle cell lymphoma in Singapore

22 November 2022 - InnoCare Pharma announced today that Hibruka (orelabrutinib) has been approved by the Health Sciences Authority of Singapore ...

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Axicabtagene ciloleucel for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma after one systemic treatment

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

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DARWIN EU welcomes first data partners

23 November 2022 - EMA has selected the first set of  data partners to collaborate with DARWIN EU, the Data Analysis ...

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BioMarin announces advancements in FDA review of Roctavian (valoctocogene roxaparvovec) for adults with severe haemophilia A

23 November 2022 - FDA no longer plans to hold an advisory committee meeting, as previously planned, to discuss the biologics ...

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CSL lands world first gene therapy with $5.3 million haemophilia treatment

23 November 2022 - Australian biotech giant CSL will bring the first gene therapy for haemophilia B to market in ...

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MSAC Secretariat publishes agenda for March 2023 MSAC meeting

23 November 2022 - The MSAC Secretariat has published a list of applications scheduled to be considered by the MSAC ...

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AbbVie announces European Commission approval of Skyrizi (risankizumab) for the treatment of moderate to severe active Crohn's disease

23 November 2022 - Third approved indication for Skyrizi (risankizumab) and the first specific IL-23 inhibitor for the treatment of Crohn's ...

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Takeda’s biologics license application for Dengue vaccine candidate (TAK-003) granted priority review by US FDA

23 November 2022 - TAK-003 is being evaluated for the prevention of Dengue disease caused by any Dengue virus serotype ...

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Palisade Bio is granted fast track designation from the US FDA for LB1148 for accelerated return of bowel function following GI surgery

22 November 2022 - Palisade Bio today announced that the US FDA has granted fast track designation to LB1148 for ...

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