FDA appoints Tracy Beth Høeg as fifth CDER head this year
The US Food and Drug Administration (FDA) has selected Tracy Beth Høeg as its new head of drug research and…
04 Dec 2025
Formosa and Rxilient sign licensing agreement for APP13007
Formosa Pharmaceuticals and Rxilient Medical have signed an exclusive licensing agreement for the commercialisation of Byqlovi, clobetasol propionate ophthalmic suspension, 0.05% (APP13007), in the Association of Southeast Asian Nations (ASEAN)…
04 Dec 2025
FDA approves Eli Lilly’s Jaypirca in relapsed or refractory CLL/SLL
Eli Lilly and Company has received approval from the US Food and Drug Administration (FDA) for the expanded use of Jaypirca (pirtobrutinib) tablets, in 100mg and 50mg doses, to treat…
03 Dec 2025
Richard Padzur to leave FDA following recent CDER leadership shift
After less than a month in his new role as head of the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), top drug regulator Richard Padzur…
03 Dec 2025
AGC Biologics to expand cell line development with ATUM partnership
AGC Biologics is set to expand its Cell Line Development Centre of Excellence through a partnership with ATUM for integrating the Leap-In transposase expression platform into its services. With this…
03 Dec 2025
Citizen Health and UCB collaborate for epilepsy drug development
Citizen Health has entered a multi-year strategic partnership with UCB for expediting drug development across five rare diseases and epilepsy. The partnership brings together Citizen Health’s AI-based patient insights and…
02 Dec 2025
FDA steps back from preclinical primate testing amid wider regulatory shift
The US Food and Drug Administration (FDA) has taken another step away from animal testing – this time through draft guidance encouraging the reduction or cessation of non-human primate toxicity…