regulatory approval

News

Viridian has fired a shot across Amgen's bows with the FDA approval of Tepezza rival Lumvoa in thyroid eye disease, a $2bn market.

News

Ibrance has become the first CDK4/6 inhibitor to be approved for a challenging subtype of breast cancer that is often resistant to current treatment.

News

Ionis' Tryngolza has been approved for severe hypertriglyceridaemia, opening the door to what the company thinks could be a $3bn market opportunity.

News

New approvals in the EU for Astellas' Padcev and Gilead's Trodelvy break new ground in the treatment of bladder and triple-negative breast cancer.

News

CARSgen Therapeutics has claimed approval in China for gastric cancer therapy satri-cel, the first CAR-T to be cleared for a solid tumour.

News

MSD has claimed new territory for pneumococcal vaccines after getting FDA approval for use of Capvaxive in vulnerable children aged two to 17.