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).
The US Food and Drug Administration (FDA) has approved Sanofi and Regeneron’s Dupixent (dupilumab) to treat prurigo nodularis in adult patients.
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.
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 Pharmaceuticals has received marketing authorisation from the European Commission (EC) for RNAi therapeutic, Amvuttra (vutrisiran), to treat hereditary transthyretin-mediated (hATTR) amyloidosis.
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.
The US Food and Drug Administration (FDA) has approved Mallinckrodt’s Terlivaz (terlipressin) for injection to treat hepatorenal syndrome (HRS).
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).
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.
China’s National Medical Products Administration (NMPA) has approved AstraZeneca’s Forxiga (dapagliflozin) to treat chronic kidney disease (CKD) in adult patients who are at risk of progression with and without type-2 diabetes (T2D).
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