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

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

The trial is scheduled to commence in the fourth quarter of this year, with subject recruitment in both Europe and the US.

By Stephanie Brown HealthDay ReporterTHURSDAY, July 10, 2025 (HealthDay News) -- The U.S. Food and Drug Administration has ...

Mumbai, Shiv Sena legislator Sanjay Gaikwad on Thursday said his act of assaulting a staffer at an MLA hostel canteen for ...

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

The FDA, in its suspension order on Wednesday evening, stated the contractor (Ajanta Caterers) had violated provisions of the ...

The Food and Drug Administration is investigating a new outbreak of foodborne illnesses and has closed an investigation of another. The new outbreak, of ...

Authorities in China have reported more than 200 children fell sick after being given food with high levels of lead. Health officials identified 233 ...

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

Maharashtra FDA suspends caterer's license at Akashwani MLA hostel in Mumbai for serving stale food, following Shiv Sena MLA ...

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.