Lilly says its investigational oral GLP-1 drug demonstrated good glycemic control in two Phase 3 trials.
FDA clears Roches Elecsys pTau 181 blood-based biomarker test for an initial Alzheimers disease assessment.
FDA releases the 12-page form FDA-483 with six observations from an inspection at Indias Hetero Labs Unit 9 API manufacturing facility.
FDA grants Akamis Bio a fast-track designation to NG-350A for treating mismatch repair-proficient locally advanced rectal cancer.
Oncologist John Burke analyzes the positive and potentially negative impacts of FDAs new guidance on overall survival as an endpoint in oncology trial...
FDA approves a bioLytical Laboratories PMA for the INSTI HIV Self Test, an at-home HIV test that delivers results in 60 seconds or less.
FDA warns New York, NY-based Allovate Therapeutics that it is illegally marketing its Allerdent toothpaste that is an unapproved new drug.
FDA warns Nesconset, NY-based LifeVac that it is illegally marketing and distributing an airway clearance device.
