International Laboratories recalls one lot of clopidogrel tablets due to a mislabeling.
CDER revises a Manual of Policies and Procedures entitled ANDA Amendments and Supplements Reviewed by the Division of Filing Review.
FDA adds new content to a question-and-answer appendix for its guidance on Conduct of Clinical Trials of Medical Products during Covid-19 Public Healt...
FDA grants Hutchison China MediTech two fast track designations for surufatinib for treating both advanced and progressive pancreatic neuroendocrine t...
NIH, FDA, CDC and the European Medicines Agency aim to develop an international strategy for a coordinated research response to the Covid-19 pandemic.
FDA approves a Seattle Genetics NDA for Tukysa (tucatinib) for use in combination with chemotherapy for treating adult patients with advanced forms of...
A southern Florida federal judge enters an emergency temporary restraining order and a preliminary injunction against Genesis II Church of Health and ...