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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Swiss National Council votes to accept FDA approved medical devices

29 November 2022 - On November 28, the Swiss Parliament National Council voted to adapt its national laws, allowing Switzerland to ...

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The Government may have taken money from the DHB hospital budget to increase PHARMAC's funding

30 November 2022 -  In this year’s budget, the Government said it has increased PHARMAC's funding by 43% over the ...

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argenx enters into agreement to acquire priority review voucher

30 November 2022 - argenx today announced an agreement to acquire a US FDA priority review voucher for $102 million. ...

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Aldeyra Therapeutics submits new drug application to the US FDA for reproxalap for the treatment of signs and symptoms of dry eye disease

29 November 2022 - Aldeyra Therapeutics today announced the submission of a new drug application to the US FDA for ...

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European Commission grants expanded marketing authorisation for Gilead’s Biktarvy for the treatment of HIV in paediatric populations

29 November 2022 - European Commission authorises a low dose tablet for HIV treatment in virologically suppressed children at least two ...

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Ripretinib for the treatment of patients with an advanced gastro-intestinal stromal tumour after three or more therapies

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

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Mepolizumab for the treatment of patients with severe chronic rhinosinusitis with nasal polyps

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

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Leo Pharma’s Adtralza approved by MHRA, EC for adolescent atopic dermatitis

29 November 2022 - The MHRA and the European Commission have approved a change to the terms of the marketing ...

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Capstone announces authorisation of biosimilar human insulin for IV infusion in Canada and EU

29 November 2022 -  Capstone announced today that a biosimilar version of human insulin received authorisation from the EMA's CHMP ...

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External consultation on the draft revised post-market review framework (deadline extension)

29 November 2022 - The Department of Health and Aged Care has received a request to extend the consultation period on ...

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Roche withdraws Tecentriq from US bladder cancer indication

29 November 2022 - Roche has voluntarily withdrawn the US indication of Tecentriq for treating a form of bladder cancer ...

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NICE’s new methods: putting innovation first, but at what cost?

28 November 2022 - Traditionally the gatekeeper to the NHS, NICE has increasingly reoriented its role towards facilitating access to innovative ...

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Caribou Biosciences announces the FDA granted regenerative medicine advanced therapy and fast track designations to CB-010, an allogeneic anti-CD19 CAR-T cell therapy

29 November 2022 - CB-010 is the first allogeneic CAR-T cell therapy in the clinic with a PD-1 knockout. ...

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Voclosporin with immunosuppressives for the treatment of patients with lupus nephritis

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

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Aravive announces fast track designation of batiraxcept for treatment of clear cell renal cell carcinoma

29 November 2022 - FDA decision based on new Phase 1b data. ...

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