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A rare disease coalition calls on the Trump administration to appoint a new CBER director who understands rare disease drug develo...[ Price : $8.95]
An FDA untitled letter cautions the Fort Myers, FL-based LeeSar drug outsourcing facility about CGMP and other violations in its p...[ Price : $8.95]
FDA warns Clifton, NJ-based Physitemp Instruments about Quality System, Medical Device Reporting, Unapproved Device, and Unique De...[ Price : $8.95]
A Courthouse New Service report outlines the competing arguments made before a three-judge appeals court panel in a case involving...[ Price : $8.95]
FDA commissioner Marty Makary says the agency is prioritizing efforts to accelerate drug development timelines beginning at the IN...[ Price : $8.95]
FDA extends by three months its review of an Orca Bio BLA for its experimental cell therapy Orca-T, indicated for treating a range...[ Price : $8.95]
Xbrane Biopharma says it plans to resubmit a BLA before June for ranibizumab, a biosimilar copy of Genentechs Lucentis, which is i...[ Price : $8.95]
Eli Lilly wins FDA approval for Foundayo (orforglipron), a once-daily oral treatment for adults with obesity or those who are over...