Regulation

ARS Pharma’s NDA accepted for neffy to treat allergic reactions of Type I

The US Food and Drug Administration (FDA) has accepted ARS Pharmaceuticals’ (ARS Pharma) new drug application (NDA) for neffy for the emergency treatment of allergic reactions of Type I, including anaphylaxis in adults and children ≥30 kg (66 lbs).

Gilead’s Kite gets EC approval for Yescarta to treat DLBCL and HGBL

Gilead Sciences company Kite has secured approval from the European Commission (EC) for Yescarta (axicabtagene ciloleucel) to treat adult patients with diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL).

EMA’s CHMP recommends approval for Novartis’ prostate cancer therapy

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 to seek FDA Orphan Drug Designation for SIS-101-ADO

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’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.