16 May 2024 - As paediatricians who take care of children in the inpatient, emergency, and primary care settings, we ...
10 May 2024 - Full results from the pivotal XTEND-Kids study added to the US label, building on the interim data ...
2 May 2024 - RMAT designation follows FDA’s review of available safety and efficacy data from the first three patients dosed ...
26 April 2024 - Kalydeco is the first and only medicine approved in the EU in this age group to ...
25 April 2024 - Medivir announced today that its selective cathepsin K inhibitor, MIV-711, has been granted rare paediatric disease designation ...
24 April 2024 - A new targeted drug combination treatment, described as a ‘step-change in care’ for children and young ...
23 April 2024 - Today, the FDA granted accelerated approval to tovorafenib (Ojemda, Day One Biopharmaceuticals) for patients 6 months ...
23 April 2024 - Today, the FDA approved lutetium Lu 177 dotatate (Lutathera, Advanced Accelerator Applications) for paediatric patients 12 ...
11 April 2024 - AstraZeneca’s Fasenra (benralizumab) is now approved by the US FDA for add-on maintenance treatment for patients ...
8 April 2024 - Dovato is now the first and only oral, two drug, single-tablet regimen available for people aged 12 ...
1 April 2024 - Site initiations scheduled for April; patient dosing expected to begin in Q2 ,2024. ...
26 March 2024 - Expanded indication includes patients under 12 years of age, based on Phase 3/4 data demonstrating safety and ...
28 March 2024 - Indication includes children ages 6 years and older and weighing at least 30 kg. ...
27 March 2024 - First and only RSV preventive option for broad infant population authorised for use in Japan. ...
25 March 2024 - TNX-2900 is a proprietary magnesium-potentiated formulation of intranasal oxytocin, a naturally occurring hormone that reduces appetite and ...