FDA Approves Additional Indication for Fibryga

Octapharma USA’s Fibryga (fibrinogen [human] lyophilized powder for reconstitution) has received U.S. Food and Drug Administration (FDA) approval for an additional indication: fibrinogen replacement in bleeding patients with acquired fibrinogen deficiency (AFD).

FDA Approves Epinephrine Nasal Spray

The U.S. Food and Drug Administration (FDA) has approved the first needle-free alternative to the EpiPen.

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.

New Test Can Accurately Predict 90 Percent of Alzheimer’s Cases

A new study has found a combined blood test for cognitive decline has a 90 percent accuracy rate in determining whether memory loss is due to Alzheimer’s disease.

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.

Universal Flu Vaccine May Be Available in Five Years

New research reveals a promising approach to a universal influenza vaccine vaccine that confers lifetime immunity against an evolving virus.

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.

Study Shows Vaccination Decision in IEI Patients Must Be Individualized

Inborn errors of immunity (IEI) increase morbidity and mortality risks, particularly from respiratory tract infections. Hence, vaccination becomes pivotal for IEI patients.