Approvals

Alnylam announces approval of GIVLAARI by US FDA

Alnylam Pharmaceuticals, the leading RNAi therapeutics company, announced today that the US Food and Drug Administration (FDA) approved GIVLAARI (givosiran) injection for subcutaneous use for the treatment of adults with acute hepatic porphyria (AHP).

Janssen gets EC approval for Darzalex combination regimen to treat multiple myeloma

The Janssen Pharmaceutical Companies of Johnson & Johnson has secured marketing authorisation from the European Commission (EC) for Darzalex (daratumumab) in combination with lenalidomide and dexamethasone (DRd) to treat newly diagnosed multiple myeloma patients who are ineligible for autologous stem cell transplant (ASCT).

FDA approves Pfizer’s biosimilar, ABRILADA (adalimumab-afzb) for multiple inflammatory conditions

Pfizer Inc. (NYSE: PFE) today announced the United States (U.S.) Food and Drug Administration (FDA) has approved ABRILADA (adalimumab-afzb), as a biosimilar to Humira (adalimumab), for the treatment of certain patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis and plaque psoriasis.

Novartis’ Adakveo approved by FDA to reduce VOCs in sickle cell disease

Novartis has secured approval for Adakveo (crizanlizumab) from the US Food and Drug Administration (FDA) for its use in sickle cell disease patients.

Qtrilmet approved in EU to treat type-2 diabetes

AstraZeneca announced that the European Commission (EC) has approved Qtrilmet (metformin hydrochloride, saxagliptin and dapagliflozin) modified-release tablets to improve glycaemic control in adults with type-2 diabetes (T2D).

Shionogi gets FDA approval for cUTI drug Fetroja

Shionogi has secured approval from the US Food and Drug Administration (FDA) for its Fetroja (cefiderocol) to treat complicated urinary tract infections (cUTI) in adult patients with limited or no alternative treatment.

X4 Pharmaceuticals receives breakthrough therapy designation from FDA for Mavorixafor to treat WHIM Syndrome

X4 Pharmaceuticals, a clinical-stage biopharmaceutical company focused on the development of novel therapeutics for the treatment of rare diseases, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for mavorixafor (X4P-001) for the treatment of adult patients with WHIM (Warts, Hypogammaglobulinemia, Infections, and Myelokathexis) syndrome, a rare, inherited, primary immunodeficiency disease caused by genetic mutations in the CXCR4 receptor gene.

FDA approves Reblozyl for treatment of anaemia in beta thalassemia

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.

Sandoz secures FDA approval for pegfilgrastim biosimilar Ziextenzo

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).