AMT-130 is a gene therapy designed to lower levels of the mutant huntingtin protein believed to drive Huntingtons disease progression.
U.S., U.K. and Canadian drug regulators announce a joint international symposium to discuss evolving regulatory expectations for clinical trials, bioe...
A federal judge sentences former CytoDyn chief executive Nader Pourhassan to 30 months in prison for misleading investors about the development of an ...
Advocacy groups urge Congress to advance legislation that would eliminate the statutory distinction between biosimilars and so-called interchangeable ...
Sanofi says its experimental antibody amlitelimab showed consistent efficacy and a favorable safety profile across multiple late-stage clinical trials...
FDA approves Guardant Healths Guardant360 CDx liquid biopsy as a companion diagnostic to identify patients with BRAF V600Emutant metastatic colorectal...
FDA says it continued to improve the speed and consistency of drug manufacturing oversight in fiscal year 2024, citing strong performance under an int...
FDA cites Asahi Kasei Finechem Co. for significant quality control deficiencies following a November inspection of the companys active pharmaceutical ...
