Sellas announces US FDA rare paediatric disease designation granted to SLS009 for the treatment of paediatric acute lymphoblastic leukaemia

24 June 2024 - Sellas Life Sciences today announced that the US FDA has granted rare paediatric disease designation to SLS009, ...

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Takeda's HyQvia approved as replacement therapy for primary humoral immunodeficiency and secondary humoral immunodeficiency in paediatric patients 2 years of age and older

21 June 2024 - Takeda Canada is pleased to announce that Health Canada has expanded the marketing authorisation for HyQvia (normal ...

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US FDA rare paediatric disease designation granted to RC220 bisantrene for the treatment of paediatric AML

18 June 2024 - Race Oncology is pleased to announce that the US FDA has extended rare paediatric disease designation ...

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Baricitinib for the treatment of patients with juvenile idiopathic arthritis

13 June 2024 - NICE is unable to make a recommendation on the use in the NHS of baricitinib (Olumiant) for ...

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Farxiga approved in the US for the treatment of paediatric type 2 diabetes mellitus

12 June 2024 - Approval based on results from T2NOW, one of the largest paediatric type 2 diabetes Phase 3 ...

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Kevzara (sarilumab) approved by FDA for the treatment of active polyarticular juvenile idiopathic arthritis

11 June 2024 - Approval in patients with pJIA weighing 63 kg or greater adds to Kevzara’s position in treating ...

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Johnson & Johnson submits supplemental new drug application to US FDA seeking expanded paediatric indication for HIV-1 therapy Prezcobix

4 June 2024 - Johnson & Johnson today announced the submission of a supplemental new drug application to the US FDA ...

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Quince Therapeutics receives US FDA fast track designation for EryDex system

3 June 2024 - Quince Therapeutics today announced that the US FDA has granted fast track designation for its EryDex System ...

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Rinvoq (upadacitinib) now available for paediatric patients two years and older with polyarticular juvenile idiopathic arthritis and psoriatic arthritis

4 June 2024 - First indications of Rinvoq (upadacitinib) for paediatric patients two years of age and older. ...

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Paediatric rare disease drug Qarziba gets green light for coverage

30 May 2024 - The Health Insurance Review and Assessment Service (HIRA) held its fourth Cancer Disease Review Committee (CDRC) ...

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FDA grants accelerated approval to selpercatinib for paediatric patients two years and older with RET-altered metastatic thyroid cancer or solid tumours

29 May 2024 - Today, the FDA granted accelerated approval to selpercatinib (Retevmo, Eli Lilly) for certain paediatric patients two ...

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Dabrafenib mesylate in combination with trametinib dimethyl sulphoxide for the treatment of children and adolescents with BRAF V600E mutation positive glioma

29 May 2024 - NICE has published final evidence-based recommendations on the use of dabrafenib mesylate (Finlee) in combination with ...

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As childhood asthma worsens, insurers restrict access to an essential medication

16 May 2024 - As paediatricians who take care of children in the inpatient, emergency, and primary care settings, we ...

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FDA approves updated Altuviiio label with expanded paediatric data confirming highly effective bleed protection in children with haemophilia A

10 May 2024 - Full results from the pivotal XTEND-Kids study added to the US label, building on the interim data ...

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Taysha Gene Therapies announces regenerative medicine advanced therapy designation granted by US FDA for TSHA-102 in Rett syndrome

2 May 2024 - RMAT designation follows FDA’s review of available safety and efficacy data from the first three patients dosed ...

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