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RSS FeedPosted 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, ...
Posted by Michael Wonder on 27 Apr 2022
Pfizer and BioNTech submit application for U.S. emergency use authorisation for a COVID-19 vaccine booster dose in children 5 through 11 years of age
26 April 2022 - Pfizer and BioNTech today submitted an application to the U.S. Food and Drug Administration (FDA) for ...
Posted by Michael Wonder on 25 Apr 2022
FDA approves first COVID-19 treatment for young children
25 April 2022 - Today, the US FDA expanded the approval of the COVID-19 treatment Veklury (remdesivir) to include paediatric ...
Posted by Michael Wonder on 01 Apr 2022
Merck provides update on FDA review of supplemental biologics license application for Vaxneuvance (pneumococcal 15 valent conjugate vaccine) for use in infants and children
1 April 2022 - - Merck today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug ...
Posted by Michael Wonder on 31 Mar 2022
ViiV Healthcare announces US FDA approval of Triumeq PD, the first dispersible single tablet regimen containing dolutegravir, a once-daily treatment for children living with HIV
30 March 2022 - The FDA approval of the first dispersible single tablet regimen containing dolutegravir increases age-appropriate treatment options ...
Posted by Michael Wonder on 30 Mar 2022
ViiV Healthcare announces US FDA approval of Cabenuva (cabotegravir, rilpivirine) for virologically suppressed adolescents living with HIV who are 12 years of age or older and weigh at least 35 kg
29 March 2022 - The expanded indication for the first and only complete long-acting HIV regimen provides an option with as ...
Posted by Michael Wonder on 23 Mar 2022
Moderna has initiated a submission to the FDA for emergency use authorization of mRNA-1273 in children 6 to under 12 years of age
23 March 2022 - Moderna today announced positive interim data from the Phase 2/3 KidCOVE study of the Moderna COVID-19 ...
Posted by Michael Wonder on 22 Mar 2022
Ascentage Pharma's MDM2-p53 inhibitor alrizomadlin (APG-115) granted rare paediatric disease designation by the US FDA for the treatment of neuroblastoma
21 March 2022 - Ascentage Pharma today announced that its novel MDM2-p53 inhibitor, alrizomadlin (APG-115), was granted a rare paediatric disease ...
Posted by Michael Wonder on 18 Mar 2022
Marinus Pharmaceuticals announces FDA approval of Ztalmy (ganaxolone) for CDKL5 deficiency disorder
18 March 2022 - Rare paediatric disease priority review voucher awarded to Marinus Pharmaceuticals by the FDA. ...
Posted by Michael Wonder on 15 Mar 2022
Myrtelle receives FDA fast track, rare paediatric disease, and orphan drug designations for its proprietary gene therapy for the treatment of Canavan disease
15 March 2022 - Myrtelle today announced that the U.S. FDA has granted fast track, rare paediatric disease and orphan ...
Posted by Michael Wonder on 02 Mar 2022
Pfizer granted FDA breakthrough therapy designation for respiratory syncytial virus (RSV) vaccine candidate for the prevention of RSV in infants from birth up to six months of age by active immunisation of pregnant women
2 March 2022 - Pfizer today announced that its respiratory syncytial virus (RSV) vaccine candidate, PF-06928316 or RSVpreF, received breakthrough ...