Approvals

Junshi Biosciences seeks UK’s marketing authorisation for toripalimab

Shanghai Junshi Biosciences has submitted a marketing authorization application (MAA) for its toripalimab to the Medicines and Healthcare products Regulatory Agency (MHRA) of the UK.

FDA grants priority review to Takeda’s BLA for dengue vaccine candidate

The US Food and Drug Administration (FDA) has accepted and granted priority review to Takeda’s biologics license application (BLA) for its investigational dengue vaccine candidate, TAK-003.

NICE recommends MSD’s pembrolizumab to treat breast cancer

The UK National Institute for Health and Care Excellence (NICE) has recommended MSD’s pembrolizumab (Keytruda) to treat early triple negative breast cancer (TNBC) for some people in England and Wales.

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.

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.