FDA issues a Warning Letter to New Life Pharma citing serious manufacturing and regulatory violations tied to the companys production of injectable we...
FDA extends by three months its review of a Sanofi BLA for a subcutaneous formulation of Sarclisa (isatuximab-irfc) for use in combination with standa...
FDA releases the form FDA-483 issued following an inspection at the Vet4U drug distribution facility in Clay, NY.
An unidentified major drug company calls on FDA to establish a process for redacting complete response letters for unapproved applications before they...
Senate Democrats, led by Ron Wyden (D-OR), introduce legislation aimed at forcing the Trump administration to disclose the terms of pricing agreements...
FDA denies a citizen petition seeking to withdraw approval of Covidiens VenaSeal vein-closure system, concluding the medical device remains safe and e...
FDA approves an expanded indication for Sanofis Tzield (teplizumab), allowing its use in children as young as one year old to delay the onset of stage...
FDA warns the University of California at San Francisco radiopharmaceutical facility about CGMP violations in its production of finished drugs.
