Regulation

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).

US FDA accepts regulatory submission for Selumetinib

AstraZeneca and Merck, known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) and granted priority review for the MEK 1/2 inhibitor selumetinib as a potential new medicine for pediatric patients aged three years and older with neurofibromatosis type 1 (NF1) and symptomatic, inoperable plexiform neurofibromas (PNs)

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.

AbbVie submits sNDA to FDA for IMBRUVICA, Rituximab combo for CLL

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).

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.

Johnson & Johnson seeks EMA approval for Ebola vaccine regimen

Johnson & Johnson announced that Janssen Pharmaceutical Companies is seeking approval from the European Medicines Agency (EMA) for an investigational Ebola vaccine regimen.

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).

Sanofi’s Fluzone quadrivalent formulation gets FDA nod in older people

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.