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

The US Food and Drug Administration has started making rejection letters that pharmaceutical companies traditionally keep ...

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 contractor, Ajanta Caterers, had violated provisions of the Food Safety and Standards Act, 2006, and the Food Safety and ...

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 ...

Ritz accidentally mislabeled peanut butter crackers as cheese crackers. After realizing the recent error, Mondelez ...

Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for patients with cancer, today ...

The U.S. Food and Drug Administration has granted full approval for Moderna's COVID-19 vaccine, Spikevax, in children aged 6 ...

Company expects to submit deucrictibant IR capsule NDA to the U.S. FDA for the on-demand treatment of HAE attacks in 1H2026 ...