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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 30 Nov 2022
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 ...
Posted by Michael Wonder on 30 Nov 2022
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 ...
Posted by Michael Wonder on 30 Nov 2022
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. ...
Posted by Michael Wonder on 30 Nov 2022
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 ...
Posted by Michael Wonder on 30 Nov 2022
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 ...
Posted by Michael Wonder on 30 Nov 2022
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 ...
Posted by Michael Wonder on 29 Nov 2022
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 ...
Posted by Michael Wonder on 29 Nov 2022
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 ...
Posted by Michael Wonder on 29 Nov 2022
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 ...
Posted by Michael Wonder on 29 Nov 2022
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 ...
Posted by Michael Wonder on 29 Nov 2022
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 ...
Posted by Michael Wonder on 29 Nov 2022
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 ...
Posted by Michael Wonder on 29 Nov 2022
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. ...
Posted by Michael Wonder on 29 Nov 2022
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 ...
Posted by Michael Wonder on 29 Nov 2022
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. ...