EMA recommends Valneva’s COVID-19 vaccine for authorisation in the EU

23 June 2022 - EMA has recommended granting a marketing authorisation for COVID-19 Vaccine (inactivated, adjuvanted) Valneva for use in ...

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EMA recommends authorisation of Nuvaxovid for adolescents aged 12 to 17

23 June 2022 - EMA’s CHMP has recommended granting an extension of indication for the COVID-19 vaccine Nuvaxovid to include use ...

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Maviret (glecaprevir/pibrentasvir) approved by Health Canada for paediatric patients with chronic hepatitis C

22 June 2022 - This approval is supported by 98.4 per cent cure rate across this group of patients who ...

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U.S. FDA approves Merck’s Vaxneuvance (pneumococcal 15 valent conjugate vaccine) for the prevention of invasive pneumococcal disease in infants and children

22 June 2022 - Clinical data supporting approval demonstrated non-inferior immune responses for all serotypes shared with PCV13 following a four ...

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Moderna receives FDA authorisation for emergency use of its COVID-19 vaccine for children 6 months of age and older

17 June 2022 - mRNA-1273 has been administered to millions of children and adolescents over the age of 6 worldwide, ...

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Pfizer-BioNTech COVID-19 vaccine receives FDA emergency use authorisation for children 6 months through 4 years of age

17 June 2022 - In a Phase 2/3 clinical trial, the Pfizer-BioNTech COVID-19 vaccine elicited a strong immune response in this ...

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Bydureon BCise (exenatide prolonged-release) approved in the EU for paediatric patients with type 2 diabetes

8 June 2022 - First once weekly GLP-1 treatment option for paediatric patients with type-2 diabetes in the EU. ...

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Irish parents ‘breaking down and crying’ as children denied life changing cystic fibrosis medication

8 June 2022 - Sarah O’Keeffe found out that her son would not be getting the medication that would improve his ...

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FDA approves Dupixent (dupilumab) as first biologic medicine for children aged 6 months to 5 years with moderate to severe atopic dermatitis

7 June 2022 - Dupixent is the first and only biologic medicine approved to treat moderate-to-severe atopic dermatitis from infancy ...

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FDA approves drug for prevention of organ rejection in paediatric recipients of heart and liver transplants

7 June 2022 - The FDA has expanded the use of CellCept (mycophenolate mofetil) to prophylaxis of organ rejection in ...

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GBT’s inclacumab and GBT601 receive U.S. FDA orphan drug and rare paediatric disease designations for the treatment of sickle cell disease

6 June 2022 - Inclacumab is a novel P selectin inhibitor currently in Phase 3 clinical trials to reduce vaso-occlusive ...

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Pfizer asks FDA to authorise COVID-19 vaccine for youngest kids

1 June 2022 - Pfizer and BioNTech announced Wednesday that they have completed their submission requesting emergency use authorisation from ...

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Health Canada OKs Pfizer COVID-19 booster shot for teens ages 16 and 17

1 June 2022 - Canada on Wednesday authorised a single booster shot of Pfizer and partner BioNTech’s COVID-19 vaccine for ...

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FDA approves label extension for Evrysdi for infants with spinal muscular atrophy under 2 months old

31 May 2022 - Evrysdi has proven efficacy in babies, children and adults with more than 5,000 patients treated to ...

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Noveome Biotherapeutics receives rare paediatric disease designation and orphan drug designation for the treatment of necrotising enterocolitis in neonates

24 May 2022 - Noveome Biotherapeutics today announced that the U.S. FDA has granted rare paediatric disease designation and orphan drug ...

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