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.

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

FDA Commissioner told NewsNation the agency is focused on fighting childhood obesity and diabetes. Dr. Marty Makary discussed ...

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 ...

The Food and Drug Administration (FDA) has accepted the New Drug Application for doravirine/islatravir (DOR/ISL) for adults with virologically-suppressed HIV-1 infection.

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

A powerful Senate committee has approved a bill that contains provisions hemp industry stakeholders say would devastate the ...

The agency disclosed a tranche of more than 200 complete response letters from the past five years, but only those involving ...

FDA researchers report that the upper end of reported consumer use (~400mg of daily CBD intake) of cannabidiol (CBD) may ...

The U.S. Food and Drug Administration released more than 200 of its so-called complete response letters from its archive on ...

Australia's drug approval system is under fire, with critics in the United States claiming it is too slow to approve ...