FDA accepts an Antares Pharma NDA resubmission Xyosted (testosterone enanthate) injection for testosterone replacement therapy.
FDA approves an expanded Vascade indication to cover 5-7F femoral venous closures.
FDA finalizes a guidance on aspects of liposome drug products evaluated through NDAs and ANDAs reviewed by CDER.
FDA describes Benefit-Risk Framework enhancements to be implemented under PDUFA 6.
FDA issues a report outlining plans to develop and then implement new resource capacity planning and modernized time reporting capabilities.
FDA releases an FDA-483 with 11 observations from an agency inspection at SCA Pharmaceuticals in Connecticut.
University of Pittsburgh researchers say that oncology drug indications are approved faster in the U.S. than in several other countries.
Chinese citizen Gao Mei Fang pleads guilty to smuggling and mail fraud charges arising from a scheme to sell mislabeled dietary supplements.