While NICE recommended the drug for patients with at least one F508del mutation, Vertex struck a reimbursement deal with NHS England for a broader population.

The firm also said it would evaluate strategic alternatives for its animal health business and close a prostate cancer vaccine trial.

An AI-based EGFR biomarker tool could preclude the need for a rapid PCR test in nearly half of advanced lung adenocarcinoma cases, a study has suggested.

The firm said the agency cited chemistry, manufacturing, and controls issues in its complete response letter, but had no concerns about product quality.

The biotech will add a pivotal Phase III cohort to its ongoing Phase I/II trial evaluating ATSN-201 in X-linked retinoschisis ...

A team at the Peter Mac is planning for first-in-human trials in five years, hoping this new therapy will eschew the ...

The Whitrod family launched Genetic Cures for Kids in the hopes of finding a treatment for their daughter with hereditary ...

Data from a Phase I trial of Avmapki Fakzynja also supports the regimen's tolerability and suggests its potential activity in ...

Using 400 real-world patient cases, the CARE platform correctly classified 99.5 percent of cases according to NCCN guidelines ...

NEW YORK – Chinese regulatory officials have approved the BRAF inhibitor Braftovi (encorafenib) in combination with Eli Lilly's EGFR-targeted monoclonal antibody Erbitux (cetuximab) for treating ...

ARPA-H, part of HHS, has earmarked up to $142 million for 10 research projects building the tools, data, and infrastructure needed to tackle treatment resistance.