FDA approves a Pfizer BLA for Zirabev (bevacizumab-bvzr), a biosimilar to Genentechs Avastin (bevacizumab).
The House passes FDAs fiscal year 2020 budget as part of HR 3055, a five-bill minibus that would give the agency a $185 million (6%) increase for FY 2...
Pfizer adds former FDA commissioner Scott Gottlieb to its board of directors.
In observance of the Fourth of July (Independence Day)holiday in the U.S., the news operations of Dickinson's FDA Webview are closed until Monday, Jul...
House Energy and Commerce Committee chairman Frank Pallone asks FDA for updated information on inspections of imported cosmetics.
FDA proposes to allow some biologic products to continue to reference drug master file information after transitioning to Public Health Service Act li...
FDA publishes an International Council on Harmonization guideline on validation of bioanalytical assays for chemical and biological drug quantificatio...
FDA posts videos explaining its Complex Innovative Trial Design pilot meeting program.