The company expects to submit a biologics license application for NTLA-2002 in 2026 and potentially launch it in the US in 2027.
In a Phase I/II trial, patients with X-linked chronic granulomatous disease will receive a treatment created using a new ...
The drug was previously available through the Cancer Drugs Fund, but with more data, NICE is backing routine access through the NHS.
The Swedish firm has treated the first two patients in a Phase I/II trial of the autologous neoantigen-directed lymphocyte therapy.
The company also continues to study Descartes-08 in other autoimmune diseases and has plans for a basket trial in pediatric patients.
The FDA didn't approve the therapy in EBV-positive post-transplant lymphoproliferative disease due to findings at a third-party manufacturing facility.
This marks the first US approval for AstraZeneca and Daiichi Sankyo's Trop-2-directed antibody drug conjugate.
The FDA also approved Qiagen's Therascreen KRAS RGQ PCR kit as a companion diagnostic to identify KRAS G12C-mutant patients.
Although Pfizer is not among the drugmakers suing the government to block negotiations, it has said the program will hinder drug R&D and innovation.
The firm will pay $45 million upfront for several new targeted agents that it plans to pair with isotopes to develop both ...
HHS is asking the court to affirm its Office of Inspector General's finding that paying for fertility services would run ...