Drug to Treat Acute Pancreatitis Granted Fast Track Designation by FDA

Panafina Inc.’s investigational new drug, RABI-767, has been granted fast track designation by the U.S. Food and Drug Administration (FDA) to treat patients with acute pancreatitis predicted to progress to severe disease.

Update on Treating Neutropenia

While neutropenia can be a life-threatening condition, physicians have many tools to treat it.

CSL Behring Adds 4 and 5 Gram Vials of ZEMAIRA

CSL Behring’s ZEMAIRA (alpha1- proteinase inhibitor [human]) is now available in 4 gram and 5 gram vials.

World’s First Gene Therapies Approved to Treat Sickle Cell Disease

The U.S. Food and Drug Administration has approved two treatments, Casgevy and Lyfgenia, representing the first cell-based gene therapies for the treatment of sickle cell disease in patients 12 years and older.

FDA Approves Repotrectinib for Non-Small Cell Lung Cancer

The U.S. Food and Drug Administration has approved Bristol Myers Squibb’s repotrectinib (Augtryo) for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer.

Fresenius Kabi’s Tyenne, a Biosimilar of Actemra, Is Approved to Treat Autoimmune Diseases

The U.S. Food and Drug Administration has approved Tyenne (tocilizumab-aazg), a biosimilar referencing tocilizumab (Actemra; Genentech), to treat multiple autoimmune diseases, including rheumatoid arthritis and juvenile idiopathic arthritis.

Selarsdi Approved as Biosimilar to Stelara to Treat Plaque Psoriasis and Psoriatic Arthritis

The U.S. Food and Drug Admini-stration has approved Selarsdi (ustekinumab-aekn) injection for subcutaneous use, as a biosimilar to Stelara, for the treatment of moderate to severe plaque psoriasis and for active psoriatic arthritis in adults and pediatric patients 6 years and older.

FDA Grants wilate Orphan Drug Exclusivity

The U.S. Food and Drug Administration (FDA) has granted orphan drug exclusivity for Octapharma’s wilate, von Willebrand factor/coagulation factor VIII complex (human) lyophilized powder for solution for intravenous injection, for routine prophylaxis to reduce the frequency of bleeding episodes in adults and children 6 years of age and older with von Willebrand disease (VWD).

FDA Approves Yimmugo, an IVIG Product, to Treat Primary Immunodeficiencies

Biotest has received approval from the U.S. Food and Drug Administration for Yimmug to treat primary immunodeficiencies in patients 2 years and older.

Cryoprecipitate, Fibrinogen Concentrates and New Pathogen Reduced Cryo Product Vie for Use in Massive Hemorrhage

Does the shorter preparation time for fibrinogen concentrates make them a reasonable option in lieu of IFC in defined patient populations experiencing massive hemorrhage?