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RSS FeedPosted by Michael Wonder on 18 Oct 2021
US FDA approves expanded indication of Gilead’s Biktarvy for treatment of HIV-1 in paediatric populations
18 October 2021 - FDA approves low dose tablet for HIV treatment in virologically suppressed children weighing at least 14 kg. ...
Posted by Michael Wonder on 12 Oct 2021
Y-mAbs’ 177Lu-omburtamab-DTPA for the treatment of patients with medulloblastoma granted rare paediatric disease designation by FDA
7 October 2021 - Y-mAbs Therapeutics today announced that the U.S. FDA has granted rare paediatric disease designation for the Company’s ...
Posted by Michael Wonder on 09 Oct 2021
FDA approves innovative treatment for paediatric patients with congenital athymia
8 October 2021 - Today, the U.S. FDA approved Rethymic for the treatment of paediatric patients with congenital athymia, a rare ...
Posted by Michael Wonder on 08 Oct 2021
Janssen submits application seeking U.S. FDA approval of Stelara (ustekinumab) for the treatment of paediatric patients with juvenile psoriatic arthritis
8 October 2021 - Application utilises extrapolation-based strategy across existing breadth of Stelara data in patients living with this chronic inflammatory ...
Posted by Michael Wonder on 07 Oct 2021
Pfizer seeks US authorisation of Covid-19 vaccine for ages 5-11
8 October 2021 - The Pfizer vaccine could soon be available for children as young as five in the United States. ...
Posted by Michael Wonder on 04 Oct 2021
ViiV Healthcare submits FDA application for first dispersible single tablet regimen containing dolutegravir for children living with HIV
4 October 2021 - ViiV Healthcare has announced it has made a regulatory submission to the U.S. FDA for approval of ...
Posted by Michael Wonder on 28 Sep 2021
Pfizer and BionNTech submit initial data to U.S. FDA from pivotal trial of COVID-19 vaccine in children 5 to <12 years of age
28 September 2021 - Formal submission to request Emergency Use Authorization to follow in the coming weeks. ...
Posted by Michael Wonder on 25 Sep 2021
FDA approves Repatha (evolocumab) in paediatric patients age 10 and older with heterozygous familial hypercholesterolaemia
24 August 2021 - Approval based on HAUSER RCT demonstrating a significant reduction in low-density lipoprotein cholesterol. ...
Posted by Michael Wonder on 21 Sep 2021
FDA approves Lexette for adolescent plaque psoriasis
21 September 2021 - Mayne Pharma is pleased to announce that the U.S. FDA has approved Lexette (halobetasol propionate) foam, ...
Posted by Michael Wonder on 10 Sep 2021
Decibel Therapeutics receives orphan drug and rare paediatric disease designations for DB-OTO for the treatment of otoferlin related congenital hearing loss
9 September 2021 - Decibel Therapeutics today announced that the U.S. FDA has granted both orphan drug designation and rare paediatric ...
Posted by Michael Wonder on 07 Sep 2021
U.S. FDA accepts for priority review supplemental new drug application for Oxbryta (voxelotor) for the treatment of sickle cell disease in children ages 4 to 11
7 September 2021 - New drug application for Oxbryta dispersible tablets also accepted for priority review. ...
Posted by Michael Wonder on 30 Aug 2021
UCB announces Briviact (brivaracetam) now FDA approved to treat partial-onset seizures in paediatric patients one month of age and older
30 August 2021 - Tablets, oral solution and intravenous dosage forms of Briviact (brivaracetam) now FDA approved as both monotherapy or ...
Posted by Michael Wonder on 25 Aug 2021
Ascendis Pharma announces U.S. FDA approval of Skytrofa (lonapegsomatropin-tcgd), the first once weekly treatment for paediatric growth hormone deficiency
25 August 2021 - Availability in the U.S. expected shortly supported by a full suite of patient support programs. ...
Posted by Michael Wonder on 27 Jul 2021
Day One receives FDA rare paediatric disease designation for DAY101 for the treatment of paediatric low grade glioma
27 July 2021 - Day One Biopharmaceuticals today announced that the U.S. FDA has granted rare paediatric disease designation to the ...
Posted by Michael Wonder on 26 Jul 2021
FDA asks Pfizer, Moderna to test their vaccines in more children to help rule out safety issues
26 July 2021 - Federal regulators have requested that vaccine companies expand their trials to test coronavirus shots in several ...