Updated COVID Vaccines Approved by FDA
The U.S. Food and Drug Administration (FDA) has approved and granted emergency use authorization for updated mRNA COVID-19 vaccines (2024-2025 formula) to include a monovalent (single) component that corresponds to the Omicron variant KP.2 strain of SARS-CoV-2.
Nasal COVID-19 Vaccine Halts Transmission of SARS-CoV-2
A study by researchers at Washington University School of Medicine in St. Louis indicates next-generation vaccines that target a virus’s points of entry — the nose and mouth — may be able to contain the spread of respiratory infections and prevent transmission.
Xembify Receives Expanded Label for PI Patients
The U.S. Food and Drug Administration (FDA) has approved an expanded label for Grifols’ XEMBIFY (20% subcutaneous immune globulin [SCIG]) to include treatment-naïve patients with primary humoral immunodeficiencies (PI).
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.