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

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

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

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

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 ...

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.

NEW YORK – The US Food and Drug Administration this week approved a new dosing schedule for Eli Lilly's anti-amyloid Alzheimer's disease drug Kisunla (donanemab), which the company said improves the ...