Blog
RSS FeedPosted 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 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 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 ...
Posted by Michael Wonder on 24 May 2022
Neuronascent receives FDA rare paediatric drug designation for NNI-351 treatment for Fragile X syndrome
24 May 2022 - Neuronascent today announced that the US FDA granted rare paediatric designation for NNI-351 for Fragile X ...
Posted by Michael Wonder on 21 May 2022
FDA approves azacitidine for newly diagnosed juvenile myelomonocytic leukaemia
20 May 2022 - Today the FDA approved azacitidine (Vidaza, Celgene) for paediatric patients with newly diagnosed juvenile myelomonocytic leukaemia. ...
Posted by Michael Wonder on 17 May 2022
FDA expands eligibility for Pfizer-BioNTech COVID-19 vaccine booster dose to children 5 through 11 years
17 May 2022 - Today, the U.S. FDA amended the emergency use authorisation for the Pfizer-BioNTech COVID-19 vaccine, authorising the use ...
Posted by Michael Wonder on 02 May 2022
SpineX receives FDA breakthrough device designation for SCiP
2 May 2022 - SpineX’s proprietary non-surgical device SCiP offers new hope for children with cerebral palsy. ...
Posted by Michael Wonder on 29 Apr 2022
Moderna files for authorisation of its COVID-19 vaccine in young children six months to under six years of age
28 April 2022 - Submission to regulators globally is based on Phase 2/3 studies of mRNA-1273 in young children. ...
Posted by Michael Wonder on 27 Apr 2022
Editas Medicine receives FDA rare paediatric disease designation for EDIT-301 for the treatment of beta thalassaemia
26 April 2022 - Editas Medicine today announced that the U.S. FDA granted rare paediatric disease designation to EDIT-301, an investigational, ...