Regulation

Boehringer Ingelheim receives EC conditional marketing approval for spesolimab

Boehringer Ingelheim has received conditional marketing authorisation from the European Commission (EC) for its new humanised selective antibody, spesolimab, to treat adult patients with generalised pustular psoriasis (GPP) flares.

Health Canada approves VBI Vaccines’ PreHevbrio for Hepatitis B

Health Canada has granted approval for VBI Vaccines’ PreHevbrio [3-antigen Hepatitis B Vaccine (Recombinant)] to prevent Hepatitis B virus (HBV) in adults.

US FDA grants fast track designation for IDEAYA’s uveal melanoma therapy

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).

EMA validates GSK’s application for myelofibrosis therapy

The European Medicines Agency (EMA) has validated GSK’s marketing authorization application (MAA) for momelotinib to treat myelofibrosis.

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.