Citius Pharmaceuticals resubmits a BLA for Lymphir (denileukin diftitox) for treating patients with relapsed or refractory cutaneous T-cell lymphoma.
Regarding safety, the most common side effects of Aurlumyn include headache, flushing, heart palpitations, fast heart rate, nausea, vomiting, dizzines...
Smiths Medical ASD recalls its Medfusion model 4000 syringe pump due to issues associated with earlier software versions.
FDA posts a final guidance entitled Charging for Investigational Drugs Under an IND Questions and Answers.
Federal Register notice: FDA announces the continuation of its Regulatory Project Management Site Tours and Regulatory Interaction Program.
An FDA advisory committee votes 13 to 1 that the benefits of Abbott's TriClip transcatheter edge-to-edge repair system outweighs the risks for treatin...
The CDER Office of Scientific Investigations (OSI) publishes its FY 2023 annual report with statistics on its consultations in the last fiscal year.
CBER publishes a standard operating policy and procedure on Section 505 (o)(4) safety labeling changes to drugs approved by NDAs and BLAs.
