Iovance Biotherapeutics submits BLA to FDA for advanced melanoma drug lifileucel
Iovance Biotherapeutics has completed submission of the Biologics License Application (BLA) for lifileucel to the US Food and Drug Administration (FDA).
Iovance Biotherapeutics has completed submission of the Biologics License Application (BLA) for lifileucel to the US Food and Drug Administration (FDA).
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).
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).