Regulation

US FDA accepts Amneal’s NDA for IPX203 to treat Parkinson’s disease

The US Food and Drug Administration (FDA) has accepted Amneal Pharmaceuticals’ new drug application (NDA) for IPX203 to treat Parkinson’s disease (PD).

UK’s MHRA approves Beyfortus (nirsevimab) to prevent RSV in infants

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has given approval to Beyfortus (nirsevimab) to prevent respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants during their first RSV season.

BeiGene receives EC marketing approval for MZL therapy

BeiGene has secured marketing authorisation from the European Commission (EC) for Brukinsa (zanubrutinib) to treat marginal zone lymphoma (MZL) in adult patients.

EMA accepts Almirall’s MAA filing for atopic dermatitis therapy

The European Medicines Agency (EMA) has accepted Almirall’s marketing authorisation application (MAA) filing for its lebrikizumab to treat moderate to severe atopic dermatitis (AD).

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.