The US FDA has given accelerated approval for Eli Lilly’s RET inhibitor as a treatment for various RET-altered paediatric cancers, making it the first drug in the class av
AstraZeneca's Soliris has become the first approved treatment in the EU for children and adolescents with generalised myasthenia gravis, a disorder that causes weakness in
Pfizer has bolstered the evidence behind its respiratory syncytial virus (RSV) vaccine with a positive trial of the shot used to protect newborns, adding to earlier results in older adults.
The US authorities have authorised use of two bivalent COVID-19 booster vaccines from Pfizer/BioNTech and Moderna – targeting the BA.4 and BA.5 subvariants of Omicron – for use in children
A submission to the US Food and Drug Administration (FDA) requesting an Emergency Use Authorization (EUA) of a 10-µg booster dose of Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for
The FDA's vaccines advisors have voted in favour of extending the use of mRNA-based COVID-19 vaccine from Moderna and Pfizer/BioNTech to include children from the ages of six months.
Disc Medicine has charted a route to market for bitopertin, its drug candidate for rare disease erythropoietic protoporphyria (EPP), after meeting with the FDA.