President Trump prepares to impose sweeping new tariffs on certain pharmaceutical imports, targeting companies that have not agreed to participate in ...
A rare disease coalition calls on the Trump administration to appoint a new CBER director who understands rare disease drug development and values the...
An FDA untitled letter cautions the Fort Myers, FL-based LeeSar drug outsourcing facility about CGMP and other violations in its production of compoun...
FDA warns Clifton, NJ-based Physitemp Instruments about Quality System, Medical Device Reporting, Unapproved Device, and Unique Device Identifier viol...
A Courthouse New Service report outlines the competing arguments made before a three-judge appeals court panel in a case involving FDAs decision to re...
FDA commissioner Marty Makary says the agency is prioritizing efforts to accelerate drug development timelines beginning at the IND stage, while also ...
FDA extends by three months its review of an Orca Bio BLA for its experimental cell therapy Orca-T, indicated for treating a range of hematologic mali...
Xbrane Biopharma says it plans to resubmit a BLA before June for ranibizumab, a biosimilar copy of Genentechs Lucentis, which is indicated for treatin...
