The US Food and Drug Administration (FDA) has granted fast track designation for IDEAYA Biosciences’ development programme studying darovasertib in combination with crizotinib to treat metastatic uveal melanoma (MUM).
The European Medicines Agency (EMA) has validated GSK’s marketing authorization application (MAA) for momelotinib to treat myelofibrosis.
Aldeyra Therapeutics has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for topical ocular reproxalap, to treat signs and symptoms of dry eye disease.
The US Food and Drug Administration (FDA) has granted fast track designation (FTD) for Kintara Therapeutics’ late-stage photodynamic therapy (PDT), REM-001, to treat cutaneous metastatic breast cancer (CMBC).
The regulatory authorities in Taiwan and South Korea have granted fast-tracked approval process for Everest Medicines’ Nefecon.
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.
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