The US Food and Drug Administration (FDA) has granted fast track designation to Arrowhead Pharmaceuticals’ ARO-APOC3 that helps to lower triglycerides in adult patients with familial chylomicronemia syndrome (FCS).
Biopharmaceutical company Everest Medicines has received approval from China’s National Medical Products Administration (NMPA) for its new drug application (NDA) related to Xerava (eravacycline) to treat complicated intra-abdominal infections (cIAI) in adults.
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).
The US Food and Drug Administration (FDA) has finished a filing review of Valneva’s Biologics License Application (BLA) for single-shot chikungunya vaccine candidate VLA1553.
LEO Pharma has received approval from Health Canada for Adtralza (tralokinumab) to treat moderate-to-severe atopic dermatitis (AD).
China’s National Medical Products Administration (NMPA) has accepted Legend Biotech’s New Drug Application (NDA) for ciltacabtagene autoleucel (cilta-cel).
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 accepted for review of Pfizer’s biologics license application (BLA) for its investigational pentavalent meningococcal vaccine candidate, MenABCWY.
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