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FDA warns Brooksville, FL-based BEO Pharmaceuticals about CGMP violations in its manufacturing of finished drugs.[ Price : $8.95]
FDA approves Abeona Therapeutics Zevaskyn (prademagene zamikeracel) gene-modified cellular sheets, an autologous cell-based gene t...[ Price : $8.95]
Two Hogan Lovells attorneys discuss lessons medical device companies can learn about AI use from a recent FDA Warning Letter to Ex...[ Price : $8.95]
A Memorial Sloan Kettering Cancer Center Phase 2 trial demonstrates the value of immunotherapy in MMRd genetic mutation cancers in...[ Price : $8.95]
In a wide-ranging Inside Medicine Substack interview, FDA commissioner Martin Makary says there will be no broad reorganization at...[ Price : $8.95]
Senator Josh Hawley (R-Mo.) urges FDA commissioner Marty Makary to review a new study allegedly revealing greater safety risks tha...[ Price : $8.95]
FDA issues Telix Pharmaceuticals a complete response letter on its NDA for Pixclara (floretyrosine F18), a positron emission tomog...[ Price : $8.95]
Pfizer says the pivotal Phase 3 CREST trial of sasanlimab in combination with standard of care met its primary endpoint as an indu...