Investigational Plasma Kallikrein Inhibitor (Sebetralstat) Reduces Time to Relief from Hereditary Angioedema Attacks
In a Phase III, double-blind, three-way crossover trial, sebetralstat given on-demand for treatment of hereditary angioedema (HAE) attacks was shown to result in faster times to the start of symptom relief, reduction in attack severity and complete attack resolution than placebo treatment.
CDC Identifies New COVID Strain Known as XEC
A newly discovered COVID strain known as XEC continues to spread rapidly across multiple countries, including the U.S.
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.
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.