Minovia Therapeutics wins an FDA orphan drug designation for its lead investigational therapy, MNV-201, for myelodysplastic syndrome.
FDA accepts for review a Chiesi NDA for a single-inhaler triple therapy designed for the maintenance treatment of asthma in adults.
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.
