Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 26 Apr 2024
FDA grants Medivir´s MIV-711 rare paediatric disease designation and orphan drug designation for the treatment of Legg-Calvé-Perthes Disease
25 April 2024 - Medivir announced today that its selective cathepsin K inhibitor, MIV-711, has been granted rare paediatric disease designation ...
Posted by Michael Wonder on 23 Apr 2024
FDA grants accelerated approval to tovorafenib for patients with relapsed or refractory BRAF altered paediatric low-grade glioma
23 April 2024 - Today, the FDA granted accelerated approval to tovorafenib (Ojemda, Day One Biopharmaceuticals) for patients 6 months ...
Posted by Michael Wonder on 23 Apr 2024
FDA approves lutetium Lu 177 dotatate for paediatric patients 12 years and older with GEP-NETs
23 April 2024 - Today, the FDA approved lutetium Lu 177 dotatate (Lutathera, Advanced Accelerator Applications) for paediatric patients 12 ...
Posted by Michael Wonder on 11 Apr 2024
Fasenra approved for treatment of children aged 6 to 11 with severe asthma
11 April 2024 - AstraZeneca’s Fasenra (benralizumab) is now approved by the US FDA for add-on maintenance treatment for patients ...
Posted by Michael Wonder on 09 Apr 2024
ViiV Healthcare announces US FDA approval of Dovato (dolutegravir/lamivudine) for adolescents living with HIV
8 April 2024 - Dovato is now the first and only oral, two drug, single-tablet regimen available for people aged 12 ...
Posted by Michael Wonder on 02 Apr 2024
Solid Biosciences receives rare paediatric disease designation from the FDA for Duchenne muscular dystrophy gene therapy candidate SGT-003
1 April 2024 - Site initiations scheduled for April; patient dosing expected to begin in Q2 ,2024. ...
Posted by Michael Wonder on 30 Mar 2024
FDA Approves Medexus's supplemental biologics license application for Ixinity to treat haemophilia B in paediatric patients
26 March 2024 - Expanded indication includes patients under 12 years of age, based on Phase 3/4 data demonstrating safety and ...