Approvals

FDA approves label expansion of Alnylam’s Oxlumo for PH1

The US Food and Drug Administration (FDA) has approved Alnylam Pharmaceuticals’ supplemental new drug application (sNDA) for the expanded use of Oxlumo (lumasiran) to treat advanced primary hyperoxaluria type 1 (PH1).

US FDA approves Sanofi and Regeneron’s Dupixent to treat prurigo nodularis

The US Food and Drug Administration (FDA) has approved Sanofi and Regeneron’s Dupixent (dupilumab) to treat prurigo nodularis in adult patients.

China’s NMPA approves AstraZeneca and Merck’s Lynparza for ovarian cancer

China’s National Medical Products Administration (NMPA) has approved AstraZeneca and Merck’s (known as MSD outside of the US and Canada) Lynparza (olaparib) as maintenance therapy for a type of ovarian cancer.

Lilly’s Retevmo receives FDA approval to treat solid tumours

Eli Lilly and Company (Lilly) has received the US Food and Drug Administration (FDA) approval for its RET kinase inhibitor, Retevmo (selpercatinib), to treat advanced or metastatic solid tumours in adult patients.

Alnylam receives EU marketing authorisation for hATTR amyloidosis therapy

Alnylam Pharmaceuticals has received marketing authorisation from the European Commission (EC) for RNAi therapeutic, Amvuttra (vutrisiran), to treat hereditary transthyretin-mediated (hATTR) amyloidosis.

Kite’ Yescarta gets CHMP positive opinion to treat large B-cell lymphoma

Gilead company Kite has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for its Yescarta (axicabtagene ciloleucel) to treat large B-cell lymphoma.

US FDA approves Mallinckrodt’s Terlivaz for injection to treat hepatorenal syndrome

The US Food and Drug Administration (FDA) has approved Mallinckrodt’s Terlivaz (terlipressin) for injection to treat hepatorenal syndrome (HRS).

AnHeart, NewG Lab receive orphan drug designation in Korea for NSCLC therapy

AnHeart Therapeutics and NewG Lab Pharma subsidiary NewG Lab Therapeutics have received orphan drug designation in Korea for the next-generation tyrosine kinase inhibitor (TKI), taletrectinib, to treat advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).

US FDA approves Revance’s Daxxify for injection to treat frown lines

The US Food and Drug Administration (FDA) has approved Revance Therapeutics’ Daxxify (DaxibotulinumtoxinA-lanm) for injection to temporarily improve moderate to severe frown lines (glabellar lines) in adults.