FDA knocks back Pharming's bid for wider Joenja use
The FDA has turned down Pharming's bid to broaden the label of Joenja for rare immunodeficiency disorder APDS so it can be used in younger patients.
Mixed data mars Sanofi's venglustat programme
Sanofi has reported positive phase 3 results with venglustat in Gauder disease, but the drug missed the mark in a Fabry disease trial.
FDA launches pilot programme to boost US manufacturing
The FDA has started accepting requests to participate in its PreCheck pilot programme, promising rapid reviews of new manufacturing facilities.
UCB bags first EU approval for rare genetic disease TK2d
UCB gets an EU recommendation for the first therapy for thymidine kinase 2 deficiency (TK2d), plus other CHMP decisions.
Lilly names Pennsylvania site for its latest US facility
Eli Lilly has revealed the fourth new manufacturing site in its $27 billion capital investment spree in the US - a $3.5bn facility in Pennsylvania.
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