FDA warns Fresenius Kabi about CGMP deviations in its Fenwal International unit in Maricao, Puerto Rico.
KVK-Tech recalls one lot of betaxolol tablets as a precautionary measure after a single oxycodone HCl tablet was found on the packaging line during th...
Federal Register notice: FDA announces an 11/16 Oncologic Drugs Advisory Committee meeting to hear an update on the agencys accelerated approval progr...
In a wide-ranging TV interview during a visit to India, FDA commissioner Robert Califf says the agency will be increasing both announced and unannounc...
FDA medical reviewers ask the Oncologic Drugs Advisory Committee whether the CodeBreak 200 post-marketing trial of Amgens Lumakras can be considered a...
AdvaMedDx says it has many questions about an immediately effective FDA guidance on a pilot of oncologic drugs that use in vitro tests.
Pfizers Hospira drug unit recalls several drug lots of 4.2% sodium bicarbonate injection, 1% lidocaine HCl injection, and 2% lidocaine HCl injection d...
FDA amends the emergency use authorization of Novavaxs Covid-19 vaccine adjuvanted, for use in individuals 12 years of age and older to include the 20...
