Regulation

China’s NMPA accepts Legend Biotech’s NDA for cilta-cel

China’s National Medical Products Administration (NMPA) has accepted Legend Biotech’s New Drug Application (NDA) for ciltacabtagene autoleucel (cilta-cel).

China’s NMPA accepts BeiGene’s sBLA for hepatocellular carcinoma treatment

The China National Medical Products Administration’s (NMPA) Center for Drug Evaluation (CDE) has accepted BeiGene’s supplemental biologics license application (sBLA) for tislelizumab to treat hepatocellular carcinoma (HCC).

US FDA accepts BLA for Pfizer’s meningococcal vaccine candidate

The US Food and Drug Administration (FDA) has accepted for review of Pfizer’s biologics license application (BLA) for its investigational pentavalent meningococcal vaccine candidate, MenABCWY.

US FDA approves Acer’s olpruva to treat urea cycle disorders

The US Food and Drug Administration (FDA) has approved Acer Therapeutics’ olpruva (sodium phenylbutyrate) to treat patients with urea cycle disorders (UCDs).

Japan’s MHLW approves MediWound’s burn treatment Nexobrid

The Japanese Ministry of Health, Labor, and Welfare (MHLW) has granted marketing authorisation for MediWound’s NexoBrid to remove nonviable burn tissue, or eschar.

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.