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The Justice Department says Affordable Healthcare Solutions pled guilty to one felony count of receiving adulterated medical devic...[ Price : $8.95]
FDA accepts for review a Regeneron Pharmaceuticals supplemental BLA for PD-1 inhibitor Libtayo (cemiplimab-rwlc) to treat certain ...[ Price : $8.95]
Eisai begins a rolling BLA submission for lecanemab, the companys investigational anti-amyloid beta protofibril antibody for treat...[ Price : $8.95]
Pfizer submits a clinical trial protocol amendment for a Phase 3 gene therapy trial for fordadistrogene movaparvovec in Duchenne M...[ Price : $8.95]
FDA and the United Kingdom expand their ongoing mutual recognition agreement to include animal drug inspections.[ Price : $8.95]
FDA alerts health care providers on recent information about the potential for differences in procedural outcomes between women an...[ Price : $8.95]
CDER director Patrizia Cavazzoni tells an industry conference that agency inspectors are emphasizing the importance of having in p...[ Price : $8.95]
FDA says it intends to exercise enforcement discretion regarding a requirement for informed consent for in vitro diagnostic device...