FDA hands Biohaven refusal to file letter

FDA approves BMS psoriasis TYK2 inhibitor

Fresenius Kabi snags its first biosimilar approval

FDA approves Imbruvica for kids with chronic graft-versus-host disease

FDA approves Axsome first rapid-acting antidepressant

UK grants Moderna first Omicron booster approval

AstraZeneca, Daiichi Sankyo grab first FDA approval for targeted HER2-low breast cancer drug