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...
FDA cites Pine Pharmaceuticals for multiple quality and sterility violations following a 10-day inspection of the companys drug outsourcing facility i...
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 ...
FDAs annual report on drug approvals says the majority of novel drugs approved in 2025 moved through accelerated regulatory pathways.
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...
