China National Medical Products Administration has accepted the review of GSK’s drug application for Nucala (mepolizumab) as an add-on maintenance treatment for severe eosinophilic asthma (SEA).
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of AbbVie’s upadacitinib to treat adult patients suffering with moderately to severely active Crohn's disease.
European Medicines Agency (EMA) has granted Orphan Drug Designation to biopharmaceutical company Sage Therapeutics’ SAGE-718 for the treatment of Huntington’s disease (HD).
LEO Pharma has received approval from Health Canada for Adtralza (tralokinumab) to treat moderate-to-severe atopic dermatitis (AD).
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).
The US Food and Drug Administration (FDA) has approved Acer Therapeutics’ olpruva (sodium phenylbutyrate) to treat patients with urea cycle disorders (UCDs).
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 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 has granted approval for VBI Vaccines’ PreHevbrio [3-antigen Hepatitis B Vaccine (Recombinant)] to prevent Hepatitis B virus (HBV) in adults.
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).
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