China’s National Medical Products Administration (NMPA) has accepted Legend Biotech’s New Drug Application (NDA) for ciltacabtagene autoleucel (cilta-cel).
03 Jan 2023
02 Jan 2023
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).
29 Dec 2022
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.
28 Dec 2022
The US Food and Drug Administration (FDA) has approved Acer Therapeutics’ olpruva (sodium phenylbutyrate) to treat patients with urea cycle disorders (UCDs).
26 Dec 2022
The Japanese Ministry of Health, Labor, and Welfare (MHLW) has granted marketing authorisation for MediWound’s NexoBrid to remove nonviable burn tissue, or eschar.
14 Dec 2022
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.
09 Dec 2022
Health Canada has granted approval for VBI Vaccines’ PreHevbrio [3-antigen Hepatitis B Vaccine (Recombinant)] to prevent Hepatitis B virus (HBV) in adults.
06 Dec 2022
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).
05 Dec 2022
The European Medicines Agency (EMA) has validated GSK’s marketing authorization application (MAA) for momelotinib to treat myelofibrosis.
30 Nov 2022
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.