FDA Approves Additional Indication for Fibryga

FDA has approved Octapharma USA’s Fibryga (fibrinogen [human] lyophilized powder for reconstitution) for fibrinogen replacement in bleeding patients with acquired fibrinogen deficiency.

FDA Modernizes Informed Consent Guidance, Aligning with Common Rule Changes

FDA has published new draft guidance on informed consent that lines up with revisions to the Common Rule made in 2017, offering up-to-date recommendations on starting the process with the sharing of essential clinical trial information in ways that patients can understand.

FDA Approves Filspari for Rare Kidney Disease IgA Nephropathy

The U.S. Food and Drug Administration has granted full approval to Travere Therapeutics’ Filspari (sparsentan) to slow kidney function decline in adults with primary IgA nephropathy.

Revita System Granted Breakthrough Device Designation by FDA

The U.S. Food and Drug Administration has granted breakthrough device designation to Revita System (Fractyl Health Inc.) for the maintenance of weight loss after discontinuation of glucagon-like peptide-1 medications.

FDA Approves Blood Test to Detect Colon Cancer

The U.S. Food and Drug Administration has approved a blood test to screen for colorectal cancer in individuals aged 45 and older with an “average risk” of colon cancer.

Deuruxolitinib Approved by FDA to Treat Severe Alopecia

Sun Pharma’s LEQSELVI (deuruxolitinib) has been approved by the U.S. Food and Drug Administration to treat severe alopecia areata in adults.

FDA Approves Epysqli, Second Biosimilar to Soliris

Samsung Bioepis’ biologics license application for Epysqli (eculizumab-aagh) as a biosimilar to Soliris (eculizumab) has been approved by the U.S. Food and Drug Administration (FDA) to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis and atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy.

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.

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.

First Treatment Approved for Genetic Clotting Disorder

The U.S. Food and Drug Administration has approved a recombinant ADAMTS13 protein product (Adzynma) as a prophylactic or on-demand enzyme replacement therapy for patients with congenital thrombotic thrombocytopenic purpura.