FDA misses a 4/29 user fee review action extension on a Stealth BioTherapeutics NDA for elamipretide, a first-in-class mitochondria-targeted therapeut...
FDA warns Amazon it is marketing unapproved and misbranded external analgesic drug products for use before sensitive cosmetic procedures.
FDA warns Brooksville, FL-based BEO Pharmaceuticals about CGMP violations in its manufacturing of finished drugs.
FDA approves Abeona Therapeutics Zevaskyn (prademagene zamikeracel) gene-modified cellular sheets, an autologous cell-based gene therapy for treating ...
Two Hogan Lovells attorneys discuss lessons medical device companies can learn about AI use from a recent FDA Warning Letter to Exer Labs.
A Memorial Sloan Kettering Cancer Center Phase 2 trial demonstrates the value of immunotherapy in MMRd genetic mutation cancers instead of surgery, ra...
Pfizer says the pivotal Phase 3 CREST trial of sasanlimab in combination with standard of care met its primary endpoint as an induction therapy with o...
J&J reports data from the Phase 2b SunRISe-1 study evaluating TAR-200, an intravesical gemcitabine releasing system, for patients with certain types o...
