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.
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.
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.
The US Food and Drug Administration (FDA) has accepted Amneal Pharmaceuticals’ new drug application (NDA) for IPX203 to treat Parkinson’s disease (PD).
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 has secured marketing authorisation from the European Commission (EC) for Brukinsa (zanubrutinib) to treat marginal zone lymphoma (MZL) in adult patients.
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).
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 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).
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).
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