ImmunoGen has secured breakthrough therapy status from the US Food and Drug Administration (FDA) for its IMGN632 to treat patients with relapsed or refractory blastic plasmacytoid dendritic cell neoplasm (BPDCN).
Bristol Myers Squibb announced that Opdivo (nivolumab) 360 mg every three weeks plus Yervoy (ipilimumab) 1 mg/kg every six weeks (injections for intravenous use) was approved by the U.S. Food and Drug Administration (FDA) for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM).
Infinity Pharmaceuticals announced today that the US Food and Drug Administration (FDA) has granted Fast Track designation for eganelisib (IPI-549) in combination with a checkpoint inhibitor and chemotherapy for the treatment of patients with inoperable locally advanced or metastatic triple-negative breast cancer (TNBC), in the first-line setting. Infinity is currently enrolling patients in MARIO-3, the Company’s ongoing Phase 2 study in collaboration with Roche/Genentech to evaluate eganelisib in a novel triple combination front-line regimen with Tecentriq and Abraxane in TNBC.
AVROBIO, a leading clinical-stage gene therapy company with a mission to free people from a lifetime of genetic disease, announced that the European Commission (EC) has granted orphan drug designation for AVR-RD-02, the company’s investigational gene therapy for the treatment of Gaucher disease.
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.
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