Amicus Therapeutics has received positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for Opfolda (miglustat) to treat late-onset Pompe disease (LOPD).
Ardelyx has resubmitted a new drug application (NDA) for Xphozah (tenapanor) to the US Food and Drug Administration (FDA).
Daiichi Sankyo has received approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for ENHERTU (trastuzumab deruxtecan), a treatment for adult patients with HER2 low (IHC 1+ or IHC 2+/ISH-) unresectable or recurrent breast cancer after prior chemotherapy.
The US Food and Drug Administration has granted fast track designation to Prestige Biopharma’s PBP1510 (Ulenistamab) to treat unresectable or metastatic pancreatic adenocarcinoma (PDAC).
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).
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).
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