Regulation

Aldeyra seeks NDA approval for dry eye disease treatment in US

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.

USFDA grants fast track designation for Kintara’s breast cancer therapy

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).

Everest Medicines announces regulatory updates in Taiwan, South Korea for Nefecon

The regulatory authorities in Taiwan and South Korea have granted fast-tracked approval process for Everest Medicines’ Nefecon.

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.