FDA cites Pine Pharmaceuticals for multiple quality and sterility violations following a 10-day inspection of the companys drug outsourcing facility i...
A Health Affairs analysis on FDAs new pathway allowing drug approvals based on a plausible mechanism of action warns that the approach raises unresolv...
Sarepta Therapeutics announces that its gene therapy Elevidys significantly slowed disease progression over three years in ambulatory patients with Du...
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 approves a Scancell Holdings IND to begin a registrational Phase 3 trial of iSCIB1+ in patients with advanced melanoma.
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 ...
