Blog
RSS FeedPosted by Michael Wonder on 18 Jul 2024
Sellas announces US FDA rare paediatric disease designation granted to SLS009 for the treatment of paediatric acute myeloid leukaemia
16 July 2024 - Opened enrollment for paediatric AML patients in on-going Phase 2 clinical trial. ...
Posted by Michael Wonder on 13 Jul 2024
Innorna announces US FDA rare paediatric disease designation granted to IN016 for the treatment of progressive familial intrahepatic cholestasis
11 July 2024 - Innorna today announced that the US FDA has granted rare paediatric disease designation to IN016, one of ...
Posted by Michael Wonder on 03 Jul 2024
The rare paediatric disease voucher program creates new treatments. I have new data to prove it.
2 July 2024 - The FDA’s rare paediatric disease priority review voucher program, which has been providing incentives for lifesaving innovations ...
Posted by Michael Wonder on 26 Jun 2024
Harmony Biosciences receives US FDA approval for Wakix (pitolisant) in paediatric patients with narcolepsy
24 June 2024 - FDA granted priority review of the sNDA in February 2024. ...
Posted by Michael Wonder on 25 Jun 2024
Sellas announces US FDA rare paediatric disease designation granted to SLS009 for the treatment of paediatric acute lymphoblastic leukaemia
24 June 2024 - Sellas Life Sciences today announced that the US FDA has granted rare paediatric disease designation to SLS009, ...
Posted by Michael Wonder on 18 Jun 2024
US FDA rare paediatric disease designation granted to RC220 bisantrene for the treatment of paediatric AML
18 June 2024 - Race Oncology is pleased to announce that the US FDA has extended rare paediatric disease designation ...
Posted by Michael Wonder on 12 Jun 2024
Farxiga approved in the US for the treatment of paediatric type 2 diabetes mellitus
12 June 2024 - Approval based on results from T2NOW, one of the largest paediatric type 2 diabetes Phase 3 ...
Posted by Michael Wonder on 11 Jun 2024
Kevzara (sarilumab) approved by FDA for the treatment of active polyarticular juvenile idiopathic arthritis
11 June 2024 - Approval in patients with pJIA weighing 63 kg or greater adds to Kevzara’s position in treating ...
Posted by Michael Wonder on 05 Jun 2024
Johnson & Johnson submits supplemental new drug application to US FDA seeking expanded paediatric indication for HIV-1 therapy Prezcobix
4 June 2024 - Johnson & Johnson today announced the submission of a supplemental new drug application to the US FDA ...
Posted by Michael Wonder on 05 Jun 2024
Quince Therapeutics receives US FDA fast track designation for EryDex system
3 June 2024 - Quince Therapeutics today announced that the US FDA has granted fast track designation for its EryDex System ...
Posted by Michael Wonder on 05 Jun 2024
Rinvoq (upadacitinib) now available for paediatric patients two years and older with polyarticular juvenile idiopathic arthritis and psoriatic arthritis
4 June 2024 - First indications of Rinvoq (upadacitinib) for paediatric patients two years of age and older. ...
Posted by Michael Wonder on 29 May 2024
FDA grants accelerated approval to selpercatinib for paediatric patients two years and older with RET-altered metastatic thyroid cancer or solid tumours
29 May 2024 - Today, the FDA granted accelerated approval to selpercatinib (Retevmo, Eli Lilly) for certain paediatric patients two ...
Posted by Michael Wonder on 16 May 2024
As childhood asthma worsens, insurers restrict access to an essential medication
16 May 2024 - As paediatricians who take care of children in the inpatient, emergency, and primary care settings, we ...
Posted by Michael Wonder on 14 May 2024
FDA approves updated Altuviiio label with expanded paediatric data confirming highly effective bleed protection in children with haemophilia A
10 May 2024 - Full results from the pivotal XTEND-Kids study added to the US label, building on the interim data ...
Posted by Michael Wonder on 06 May 2024
Taysha Gene Therapies announces regenerative medicine advanced therapy designation granted by US FDA for TSHA-102 in Rett syndrome
2 May 2024 - RMAT designation follows FDA’s review of available safety and efficacy data from the first three patients dosed ...