U.S. FDA approves new paediatric formulation of Sirturo (bedaquiline) as part of combination therapy to treat children with pulmonary multidrug-resistant tuberculosis

27 May 2020 - The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. FDA has granted ...

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FDA approves first treatment for a form of bladder dysfunction in paediatric patients as young as 2 years of age

26 May 2020 - The U.S. FDA today granted approval to VESIcare LS (solifenacin succinate) oral suspension for the treatment of ...

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FDA approves Dupixent (dupilumab) as first biologic medicine for children aged 6 to 11 years with moderate-to-severe atopic dermatitis

26 May 2020 - In the pivotal trial, more than twice as many children achieved clear or almost clear skin and ...

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Passage Bio receives rare paediatric disease designation for PBGM01 for patients with GM1 gangliosidosis

21 May 2020 - PBGM01 to enter the clinic in fourth quarter of 2020. ...

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B.C. teen with rare disease wins fight to receive costly drug from province

19 May 2020 - Health ministry won't explain change of heart in granting Miles Ambridge treatment for spinal muscular atrophy. ...

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Seelos Therapeutics receives rare paediatric disease designation for SLS-005 (trehalose) in Sanfilippo syndrome

15 May 2020 - Seelos Therapeutics today announced it has been granted rare paediatric disease designation for SLS-005 in Sanfilippo ...

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FDA grants paediatric disease designation for Mateon's CA4P

5 May 2020 - Treatment of stage IIB–IV melanoma due to genetic mutations that disproportionately affect paediatric patients. ...

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FDA approves Fensolvi (leuprolide acetate) for injectable suspension for paediatric patients with central precocious puberty

4 May 2020 - Fensolvi is the only six-month, subcutaneously administered leuprolide acetate approved for the treatment of paediatric patients two ...

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Vertex receives European CHMP positive opinion for Kalydeco (ivacaftor) for children and adolescents with cystic fibrosis between the ages 6 months and 18 years with the R117H mutation in the CFTR gene

1 May 2020 - If approved, Kalydeco (ivacaftor) will be the first and only medicine in Europe to treat the underlying ...

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'New Zealand doesn't have help juice' - PHARMAC's decision leaves family stuck abroad

3 May 2020 - Kristie Yeoman says returning home would likely mean death for her daughter. ...

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FDA approves Ortho Dermatologics' labeling for Jublia (efinaconazole) 10% topical solution in patients as young as six years old

29 April 2020 - Ortho Dermatologics today announced today announced the U.S. FDA has approved a supplemental new drug application for ...

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Janssen announces submission of two applications to U.S. FDA seeking approval of Simponi Aria (golimumab) for the treatment of polyarticular juvenile idiopathic arthritis and juvenile psoriatic arthritis

24 April 2020 - Submissions demonstrate Janssen’s commitment to developing new options for young patients. ...

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FDA approves first therapy for children with debilitating and disfiguring rare disease

10 April 2020 - Today, the U.S. FDA approved Koselugo (selumetinib) for the treatment of paediatric patients, 2 years of age ...

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Blaze Bioscience announces FDA has granted fast track designation to BLZ-100 (tozuleristide) for paediatric central nervous system tumours

7 April 2020 - Phase 2/3 pivotal trial ongoing in patients up to 30 years of age undergoing surgery for paediatric ...

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Lilly's Taltz (ixekizumab) receives U.S. FDA approval for the treatment of paediatric patients with moderate to severe plaque psoriasis

30 March 2020 - Taltz is the first and only IL-17A antagonist approved to treat this population. ...

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