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...
Eli Lilly wins FDA approval for Foundayo (orforglipron), a once-daily oral treatment for adults with obesity or those who are overweight with related ...
Former FDA commissioner Robert Califf says form FDA-483 is a useful regulatory tool for identifying issues that companies should correct, but it shoul...
