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 ...

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

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 ...

Based on data from the BEACON and NAUTICAL studies, regulatory authorities greenlit the combo for later-line patients.

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 ...

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