Federal Register proposed rule: FDA proposes to amend its regulations concerning the use of master files for biological products.
FDA approves a Janssen Pharmaceutical Companies Darzalex (daratumumab) in combination with lenalidomide and dexamethasone for treating patients with n...
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...