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...
FDA sends Galderma a complete response letter on its BLA for relabotulinumtoxinA (QM-1114), indicated for treating frown lines and crows feet in certa...
FDA releases a final guidance entitled Electronic Submission Template for Medical Device 510(k) Submissions.
FDA sends Eli Lilly a complete response letter due to inspection problems impacting its BLA for lebrikizumab, indicated for treating moderate-to-sever...
