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RSS FeedPosted by Michael Wonder on 23 Jun 2022
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 ...
Posted by Michael Wonder on 23 Jun 2022
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 ...
Posted by Michael Wonder on 23 Jun 2022
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 ...
Posted by Michael Wonder on 22 Jun 2022
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 ...
Posted by Michael Wonder on 18 Jun 2022
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, ...
Posted by Michael Wonder on 18 Jun 2022
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 ...
Posted by Michael Wonder on 09 Jun 2022
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. ...
Posted by Michael Wonder on 08 Jun 2022
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 ...
Posted by Michael Wonder on 07 Jun 2022
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 ...
Posted by Michael Wonder on 07 Jun 2022
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 ...
Posted by Michael Wonder on 06 Jun 2022
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 ...
Posted by Michael Wonder on 02 Jun 2022
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 ...
Posted by Michael Wonder on 02 Jun 2022
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 ...
Posted by Michael Wonder on 31 May 2022
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 ...
Posted by Michael Wonder on 25 May 2022
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 ...