Eisai begins a rolling BLA submission for lecanemab, the companys investigational anti-amyloid beta protofibril antibody for treating early Alzheimers...
Pfizer submits a clinical trial protocol amendment for a Phase 3 gene therapy trial for fordadistrogene movaparvovec in Duchenne Muscular Dystrophy pa...
Federal Register notice: FDA announces a 10/13-14 public workshop entitled Analgesic Clinical Trial Designs, Extrapolation, and Endpoints in Patients ...
Eli Lilly recalls one lot of its Glucagon Emergency Kit for Low Blood Sugar after receiving a product complaint reporting that a vial of glucagon was ...
FDA accepts for review two Bristol Myers Squibb supplemental BLAs for Opdivo (nivolumab) in combination with Yervoy (ipilimumab) and Opdivo in combina...
FDA and the United Kingdom expand their ongoing mutual recognition agreement to include animal drug inspections.
FDA alerts health care providers on recent information about the potential for differences in procedural outcomes between women and men undergoing imp...
CDER director Patrizia Cavazzoni tells an industry conference that agency inspectors are emphasizing the importance of having in place effective risk-...