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FDA misses a 4/29 user fee review action extension on a Stealth BioTherapeutics NDA for elamipretide, a first-in-class mitochondri...[ Price : $8.95]
FDA warns Amazon it is marketing unapproved and misbranded external analgesic drug products for use before sensitive cosmetic proc...[ Price : $8.95]
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]
Pfizer says the pivotal Phase 3 CREST trial of sasanlimab in combination with standard of care met its primary endpoint as an indu...[ Price : $8.95]
J&J reports data from the Phase 2b SunRISe-1 study evaluating TAR-200, an intravesical gemcitabine releasing system, for patients ...