FDA publishes a guidance with recommendations for submitting clinical trial data sets for response assessments for treatments of acute leukemias.
Pfizer says its Tukysa met the progression-free survival endpoint in the HER2CLIMB-05 breast cancer trial combining Tukysa with standard of care in ce...
FDA accepts for review a Rocket Pharmaceuticals BLA resubmission for Kresladi (marnetegragene autotemcel), a gene therapy for severe Leukocyte Adhesio...
FDA approves an expanded indication for Teva and Medincells Uzedy (risperidone) to permit its use as monotherapy or adjunctive therapy to lithium or v...
Tvardi Therapeutics says its experimental drug TTI-101 failed to show benefit in a Phase 2 clinical trial for idiopathic pulmonary fibrosis.
Regeneron says new clinical data show its investigational gene therapy DB-OTO has restored meaningful hearing in nearly all children treated for rare ...
FDA extends by three months its review of a Denali Therapeutics BLA for tividenofusp alfa, a potential treatment for Hunter syndrome.
FDA approves an expanded indication for Medtronics Endurant II/IIs Stent Graft System, allowing its use in abdominal aortic aneurysm patients with sho...
