AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for IMBRUVICA (ibrutinib) in combination with rituximab for the first-line treatment of younger patients (70 years old or younger) with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
The US Food and Drug Administration (FDA) has approved Reblozyl (luspatercept-aamt) for the treatment of anaemia in beta thalassemia in adults needing regular red blood cell (RBC) transfusions.
Johnson & Johnson announced that Janssen Pharmaceutical Companies is seeking approval from the European Medicines Agency (EMA) for an investigational Ebola vaccine regimen.
Novartis’ Sandoz unit has secured approval for Ziextenzo (pegfilgrastim-bmez), a biosimilar to Amgen’s Neulasta (pegfilgrastim) from the US Food and Drug Administration (FDA).
Sanofi’s Fluzone High-Dose Quadrivalent (Influenza Vaccine) has secured approval from the US Food and Drug Administration (FDA) for its use in adults, aged 65 and over.
Roche announced that the European Medicines Agency (EMA) has validated the company’s Marketing Authorisation Application (MAA) for satralizumab for the treatment of adult and adolescent patients with neuromyelitis optica spectrum disorder (NMOSD), granting it Accelerated Assessment.
Terns Pharmaceuticals has secured fast track designation from the US Food and Drug Administration (FDA) for its TERN-101 investigational farnesoid X receptor (FXR) agonist to treat non-alcoholic steatohepatitis (NASH).
Pfizer and Merck KGaA announced that the European Commission (EC) has approved Bavencio (avelumab) in combination with axitinib as a first-line treatment for adult patients with advanced renal cell carcinoma (RCC).
Astellas Pharma’s Xospata (gilteritinib) has secured approval from the European Commission (EC) as a monotherapy for the treatment of acute myeloid leukaemia (AML).
Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company with a primary focus in hematology and oncology, announced today that the company submitted an updated Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ROLONTIS (eflapegrastim).
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