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.
Immune Globulin and Prophylactic Antibiotics Provide Similar Efficacy in Treating Hypogammaglobulinemia Secondary to Hematological Malignancy
Immune globulin replacement and prophylactic antibiotics are commonly used to prevent infections in patients with secondary hypogammaglobulinemia due to hematological malignancies but have never been directly compared.
