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RSS FeedPosted by Michael Wonder on 04 Dec 2022
EMA validates application for arpraziquantel to treat schistosomiasis in pre-school aged children
2 December 2022 - Merck, a leading science and technology company, and the Pediatric Praziquantel Consortium, today announced that the EMA ...
Posted by Michael Wonder on 30 Nov 2022
European Commission grants expanded marketing authorisation for Gilead’s Biktarvy for the treatment of HIV in paediatric populations
29 November 2022 - European Commission authorises a low dose tablet for HIV treatment in virologically suppressed children at least two ...
Posted by Michael Wonder on 29 Nov 2022
Leo Pharma’s Adtralza approved by MHRA, EC for adolescent atopic dermatitis
29 November 2022 - The MHRA and the European Commission have approved a change to the terms of the marketing ...
Posted by Michael Wonder on 21 Nov 2022
'Heartbreaking': parents of sick 11 month old want greater meningitis awareness
19 November 2022 - A cough quickly turned into a “horrible” few weeks for an Auckland family whose infant son ...
Posted by Michael Wonder on 15 Nov 2022
Expansion of access to MenB vaccine urgently needed
15 November 2022 - Meningococcal B is a rare but very serious disease, causing death and serious long-term disabilities. Even when ...
Posted by Michael Wonder on 15 Nov 2022
ATAGI recommendations on use of the Pfizer COVID-19 vaccine for children aged 6 months to 4 years
15 November 2022 - On 29 September 2022, the TGA provisionally approved Comirnaty (Pfizer) COVID-19 vaccine for use in children ...
Posted by Michael Wonder on 15 Nov 2022
PerkinElmer announces its EONIS SCID-SMA kit is first to receive marketing authorisation by US FDA for SMA screening in newborns
14 November 2022 - Building on its contributions to newborn screening globally, PerkinElmer’s latest FDA authorised assay enables the simultaneous ...
Posted by Michael Wonder on 11 Nov 2022
Pfizer and BioNTech receive positive CHMP opinion for Omicron BA.4/BA.5 adapted bivalent COVID-19 vaccine booster for children 5 through 11 years of age in European Union
10 November 2022 - Pfizer and BioNTech today announced a booster dose of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine (Comirnaty Original/Omicron ...
Posted by Michael Wonder on 11 Nov 2022
Akari Therapeutics granted FDA rare paediatric disease designation of nomacopan for the treatment of paediatric HSCT-TMA
10 November 2022 - Akari Therapeutics today announced the US FDA has granted the rare paediatric disease designation to nomacopan for ...
Posted by Michael Wonder on 10 Nov 2022
Seagen announces US FDA approval of new indication for Adcetris (brentuximab vedotin) for children with previously untreated high risk Hodgkin's lymphoma
10 November 2022 - Approval based on Phase 3 clinical trial that demonstrated a 59% reduction in risk of disease ...
Posted by Michael Wonder on 10 Nov 2022
MHRA extends Cosentyx licence for paediatric arthritis
9 November 2022 - Data demonstrates that secukinumab shows a significantly longer time to flare versus placebo ...
Posted by Michael Wonder on 07 Nov 2022
Sensorion announces US FDA grants rare paediatric disease designation to OTOF-GT for the treatment of otoferlin gene-mediated hearing loss
7 November 2022 - OTOF-GT targets the restoration of hearing in people living with otoferlin deficiency. ...
Posted by Michael Wonder on 03 Nov 2022
Advocate 'gutted' as PHARMAC reviews blanket funding of child cancer medicines
2 November 2022 - Rule 8.1b of the Pharmaceutical Schedule allows all child cancer medicines to be funded by PHARMAC. ...
Posted by Michael Wonder on 02 Nov 2022
US FDA approves Vemlidy (tenofovir alafenamide) for treatment of chronic hepatitis B virus infection in paediatric patients
2 November 2022 - Approval expands on previous FDA approval of Vemlidy in adults living with this chronic liver disease. ...
Posted by Michael Wonder on 02 Nov 2022
Forget a Christmas miracle - PHARMAC consults on making the ultimate sacrifice
2 November 2022 - Today PHARMAC released a discussion paper titled Funding of Paediatric Cancer Treatments in New Zealand. ...