Charles River Laboratories names former FDA principal deputy commissioner Namandj N. Bumpus as chair a new global scientific advisory board to guide t...
FDA warns of serious complications associated with certain uses of radiofrequency microneedling devices, commonly used in aesthetic skin treatments.
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.