The FDA has authorised up to 15 clinical sites to take part in the study.
The FDA accepted an application for ivonescimab with chemotherapy for patients with lung cancer driven by EGFR changes after ...
A five-year-old patient dosed with RGX-111 has developed a brain tumour four years after being dosed with the gene therapy.
Studies of Hunter and Hurler syndromes on hold ...
The Food and Drug Administration paused trials for two experimental gene therapies from Regenxbio after one child developed a ...
Ivonescimab's BLA acceptance is a milestone for PD-1/VEGF bispecific antibodies in the U.S., potentially transforming ...
The FDA warned Corcept Therapeutics that it would face significant hurdles if it submitted its lead rare disease asset for ...
The FDA issued draft guidance Jan. 21 proposing the use of minimal residual disease and complete response as primary endpoints to support accelerated approval of drugs for multiple myeloma. The draft ...
The company said Tuesday that the FDA lifted the hold on an Investigational New Drug Application for a phase 3 clinical trial of nexiguran ziclumeran, or nex-z, for patients with a genetic disease ...
By Maggie Fick and Michael Erman SAN FRANCISCO, Jan 26 (Reuters) - Artificial intelligence has yet to deliver on the most ...
The collaboration marks a turning point in AI-driven drug design and trial forecasting, de-risking the drug development ...