The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion and recommended a marketing authorisation for Novartis’ Pluvicto (177Lu-PSMA-617 or lutetium vipivotide tetraxetan) to treat prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC).
SiSaf has initiated the process to obtain an Orphan Drug Designation from the US FDA for its siRNA therapeutic, SIS-101-ADO, to treat rare genetic skeletal disorders.
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.
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.
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.
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.
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