Pfizer and Astellas’ Xtandi (enzalutamide) has improved overall survival (OS) in patients with non-metastatic ...

The U.S. Food and Drug Administration has published more than 200 complete response letters, or decision letters, sent as ...

The FDA has issued more than 200 complete response letters, which detail reasons for non-approval of drug applications.

Florida’s importation program hasn’t brought in a single Canadian drug. It’s not cost-effective and it could be dangerous.

The Food and Drug Administration uses import alerts to enforce U.S. food safety regulations for food from foreign countries. The agency updates and ...

To mark his first 100 days as head of the FDA, Martin Makary is touting his efforts to change the agency’s operations. The Food and Drug Administration ...

A member of Columbia University's Board of Trustees is calling on the school to comply with the Trump administration's ...

US regulators approved Moderna Inc.’s COVID-19 vaccine for children, but for a narrower group than before, continuing Robert ...

The letters, many of which were already available online, detail why the regulators initially declined to approve some drugs.

A CDC advisory panel vote to recommend against use of seasonal influenza vaccines containing small amounts of thimerosal ...

The Canadian government is currently considering approving the entry of gene-edited pigs into the food system.

The Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) for decitabine/cedazuridine plus venetoclax to treat adults with newly diagnosed acute myeloid leukemia ...