Pfizer's COVID-19 vaccine (Comirnaty) provisionally approved for use as a booster in individuals aged 16-17 years old

28 January 2022 - The Therapeutic Goods Administration has provisionally approved the Pfizer COVID-19 vaccine, Comirnaty for use as a ...

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Lantern Pharma receives rare paediatric disease and orphan drug designations for LP-184 for the treatment of atypical teratoid rhabdoid tumour

24 January 2022 - Lantern Pharma today announced that the U.S. FDA has granted both rare paediatric disease designation and orphan ...

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Catalyst Biosciences receives rare paediatric disease designation for CB 4332 for the treatment of CFI deficiency

25 January 2022 - Catalyst Biosciences today announced the U.S. FDA has granted rare paediatric disease designation for CB 4332 for ...

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Genentech’s Evrysdi (risdiplam) granted FDA priority review for treatment of presymptomatic babies under 2 months of age with spinal muscular atrophy

24 January 2022 - Interim data submitted to the FDA show majority of pre-symptomatic babies treated with Evrysdi for at least ...

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Pfizer and OPKO provide update on the biologics license application for somatrogon for paediatric growth hormone deficiency

21 January 2022 - Pfizer and OPKO Health announced today that the U.S. FDA issued a complete response letter for the ...

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Japan’s MHLW approves Pfizer and OPKO’s Ngenla (somatrogon), a new long-acting treatment for paediatric growth hormone deficiency

20 January 2022 - Ngenla offers a new once weekly treatment option for children living with growth hormone deficiency. ...

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Immunotherapy with blinatumomab improves the chances of survival in very rare childhood blood cancer

20 January 2022 - The Federal Joint Committee (G-BA) today classified the additional benefit of the active ingredient blinatumomab as significant ...

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Ascendis Pharma receives European Approval for TransCon hGH for paediatric growth hormone deficiency

13 January 2022 - TransCon hGH (approved by the European Commission as Lonapegsomatropin Ascendis Pharma) is a once-weekly prodrug of somatropin ...

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Otsuka and Lundbeck announce FDA approval of supplemental new drug application for Rexulti (brexpiprazole) to treat schizophrenia in paediatric patients ages 13-17

6 January 2022 - Otsuka and Lundbeck announce the U.S. FDA has approved the supplemental new drug application of Rexulti ...

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U.S. FDA approves Immix Biopharma rare paediatric disease designation for IMX-110 as a treatment for life-threatening paediatric cancer

3 January 2021 - Immix Biopharma announced today that the U.S. FDA has granted rare paediatric disease designation for IMX-110 for ...

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FDA takes multiple actions to expand use of Pfizer-BioNTech COVID-19 Vaccine

3 January 2021 - Today, the U.S. FDA amended the emergency use authorisation for the Pfizer-BioNTech COVID-19 Vaccine to: ...

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Children and young people set to benefit from new treatment for peanut allergy

23 December 2021 - Children and young people aged between 4 and 17 with a peanut allergy could be set to ...

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Novartis Cosentyx receives FDA approval for the treatment of children and adolescents with enthesitis related arthritis and psoriatic arthritis

22 December 2021 - New approvals are based on JUNIPERA trial data showing Cosentyx (secukinumab) demonstrated reduced flare risk versus placebo ...

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Pfizer and BioNTech submit updated longer-term follow-up data of Comirnaty in adolescents 12 through 15 years of age to EMA

23 December 2021 - Pfizer and BioNTech today announced that they have submitted longer-term follow-up data from the companies’ pivotal Phase ...

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FDA approves drug to treat, help prevent types of blood clots in certain pediatric populations

20 December 2021 - FDA has approved Xarelto (rivaroxaban) as tablets and an oral suspension to treat venous thromboembolism, or blood ...

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