Regulation

Eligo’s EB003 receives FDA Orphan Drug Designation and RPD designation

Eligo Bioscience has received Orphan Drug Designation (ODD) and Rare Pediatric Disease (RPD) designation from the US Food and Drug Administration (FDA) for its microbiome gene therapy, EB003.

China’s NMPA approves sNDA for JW Therapeutics’ follicular lymphoma therapy

The China National Medical Products Administration (NMPA) has approved the supplemental New Drug Application (sNDA) for JW Therapeutics’ relmacabtagene autoleucel injection to treat relapsed or refractory follicular lymphoma.

China approves Innovent sNDA for hepatocellular carcinoma treatment

The China National Medical Products Administration (NMPA) has approved Innovent Biologics’ supplemental New Drug Application (sNDA) for Cyramza (ramucirumab) to treat hepatocellular carcinoma (HCC) patients.

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.