Regulation

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.

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).