Pfizer has secured approval from the US Food and Drug Administration (FDA) for its Xeljanz (tofacitinib) to treat children and adolescents two years and older with active polyarticular course juvenile idiopathic arthritis (pcJIA).
Gilead Sciences and Galapagos announced that the European Commission (EC) has granted marketing authorization for Jyseleca (filgotinib 200 mg and 100 mg tablets), a once-daily, oral, JAK1 inhibitor for the treatment of adults with moderate to severe active rheumatoid arthritis (RA) who have responded inadequately to, or are intolerant to, one or more disease modifying anti-rheumatic drugs (DMARDs). Jyseleca may be used as monotherapy or in combination with methotrexate (MTX).
GlaxoSmithKline (GSK) has secured approval from the US Food and Drug Administration (FDA) for its Nucala (mepolizumab) for the treatment of hypereosinophilic syndrome (HES), a rare and under-diagnosed disorder.
Sanofi and Regeneron Pharmaceuticals have secured breakthrough therapy status from the US Food and Drug Administration (FDA) for Dupixent (dupilumab) to treat patients 12 years and older with eosinophilic esophagitis (EoE).
Terns Pharmaceuticals, Inc., a biopharmaceutical company focused on developing best-in-class single-agent and combination therapies to treat liver disease, announced that TERN-201, a semicarbazide-sensitive amine oxidase (SSAO) inhibitor, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of non-alcoholic steatohepatitis (NASH).
GlaxoSmithKline and Innoviva announced the US Food and Drug Administration (FDA) has approved a new indication for Trelegy Ellipta (fluticasone furoate / umeclidinium / vilanterol ‘FF/UMEC/VI’) for the treatment of asthma in patients aged 18 years and older adding to its current license for use in patients with chronic obstructive pulmonary disease (COPD). Trelegy Ellipta is not indicated for relief of acute bronchospasm.
Ascentage Pharma (6855.HK), a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, today announced that the US Food and Drug Administration (FDA) has granted APG-2575, a novel Bcl-2 inhibitor being developed by the company, an Orphan Drug Designation (ODD) for the treatment of chronic lymphocytic leukemia (CLL). This is the second ODD granted for APG-2575, following the previous ODD granted by the FDA in July for the treatment of Waldenström Macroglobulinemia (WM).
Janssen Pharmaceutical, part of Johnson & Johnson, has secured approval from the European Commission (EC) for expanded use of Imbruvica (ibrutinib) in combination with rituximab for previously untreated adult patients with chronic lymphocytic leukaemia (CLL).
Roche has secured approval from the US Food and Drug Administration (FDA) for its Gavreto (pralsetinib) to treat adults with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test.
Eli Lilly has secured approval from the US Food and Drug Administration (FDA) for two additional doses of Trulicity to treat type 2 diabetes.
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