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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Mepolizumab for the treatment of patients with severe hypereosinophilic syndrome

29 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 eosinophilic granulomatosis with polyangiitis

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

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Health Canada has approved Sotyku (deucravacitinib tablets), an oral treatment for adults with moderate to severe plaque psoriasis

28 November 2022 - Sotyktu is the first and only approved TYK2 inhibitor in Canada and represents an important milestone ...

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FDA looks to modelling and simulation tools to streamline product reviews

28 November 2022 - The US FDA recently published a report on how it uses modelling and simulation, highlighting the untapped ...

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Type 2 diabetes drug shortage: Victoria’s Ozempic, Trulicity supplies limited until March

28 November 2022 - Type 2 diabetes sufferers are spending hours driving around the suburbs begging pharmacists for a drug that’s ...

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Croma Australia, a subsidiary of Hugel Aesthetics, receives TGA approval in Australia for Letybo (letibotulinumtoxinA) for the treatment of glabellar lines

28 November 2022 - Approval is supported by positive results from three completed Phase 3 trials that enrolled more than 1000 ...

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Ferinject approved in China for the treatment of iron deficiency in adult patients

28 November 2022 - China has the world’s largest iron deficiency anaemia population with estimated prevalence of 15%. ...

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'Reimbursement criteria for CGRP inhibiting migraine drugs not realistic'

28 November 2022 - The CGRP (calcitonin gene-related peptide) inhibitors, developed to prevent adult migraines, have recently been registered on ...

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Lantheus announces the approval of Definity (perflutren lipid microsphere) by China’s NMPA

28 November 2022 - Definity is the leading diagnostic ultrasound enhancing agent for patients with suboptimal echocardiograms. ...

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Bayer’s Nubeqa receives MHRA approval to treat metastatic prostate cancer

28 November 2022 - The treatment will be made available immediately through an early access deal with NHS England. ...

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Joint statement: NICE and SMC/HIS collaboration

25 November 2022 - NICE and SMC/HIS collaboration on the health technology appraisal of tixagevimab–cilgavimab (Evusheld) for preventing COVID-19. ...

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NICE recommends Rinvoq (upadacitinib) as treatment option for moderately to severely active ulcerative colitis in adults

25 November 2022 - Publication of positive Final Draft Guidance from NICE is supported by data from three clinical studies that ...

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Sarepta Therapeutics announces that US FDA has accepted for filing and granted priority review for the biologics license application for SRP-9001, Sarepta’s gene therapy for the treatment of ambulant individuals with Duchenne muscular dystrophy

28 November 2022 - Regulatory action date of 29 May 2023. ...

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Kintara Therapeutics granted fast track designation from FDA for REM-001 for cutaneous metastatic breast cancer

28 November 2022 - Kintara Therapeutics today announced that the US FDA has granted fast track designation to Kintara's REM-001 ...

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An open letter to doctors from the TGA

28 November 2022 - The TGA welcomes feedback and is committed to continuously improving processes and communications.  ...

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