25 April 2024 - Medivir announced today that its selective cathepsin K inhibitor, MIV-711, has been granted rare paediatric disease designation ...
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 ...
25 March 2024 - TNX-2900 is a proprietary magnesium-potentiated formulation of intranasal oxytocin, a naturally occurring hormone that reduces appetite and ...
25 March 2024 - Argenica Therapeutics is pleased to announce the US FDA has granted its neuroprotective drug ARG-007 rare ...
21 March 2024 - Lisata Therapeutics today announced that the US FDA has granted rare paediatric disease designation to LSTA1, the ...
20 March 2024 - A new gene therapy for the fatal genetic disorder metachromatic leukodystrophy, or MLD, will carry a ...
18 March 2024 - Today, the US FDA approved Lenmeldy (atidarsagene autotemcel), the first FDA approved gene therapy indicated for the ...
13 March 2024 - PepGen today announced that the US FDA granted both orphan drug and rare paediatric disease designations for ...
11 March 2024 - Approval extends treatment of Praluent to children aged 8 and older with heterozygous familial hypercholesterolaemia. ...
6 March 2024 - Today, the FDA approved inotuzumab ozogamicin (Besponsa, Pfizer) for paediatric patients 1 year and older with ...