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 ...

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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 ...

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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 ...

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'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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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MHRA extends Cosentyx licence for paediatric arthritis

9 November 2022 - Data demonstrates that secukinumab shows a significantly longer time to flare versus placebo ...

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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. ...

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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. ...

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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. ...

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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.  ...

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