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 issues a Warning Letter to New Life Pharma citing serious manufacturing and regulatory violations tied to the companys production of injectable we...
Researchers describe FDA and congressional actions that will improve the ability of the new plausible mechanism pathway to lead to the development of ...
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...
Gilead calls on FDA to rescind its decision to file a Cipla 505(b)(2) NDA for an apparent duplicate of Gileads Descovy.
FDA releases the form FDA-483 issued following an inspection at the Vet4U drug distribution facility in Clay, NY.
FDA denies a citizen petition seeking to withdraw approval of Covidiens VenaSeal vein-closure system, concluding the medical device remains safe and e...
