Immuneering Granted FDA Fast Track Designation for IMM-1-104 in Advanced Melanoma
The U.S. Food and Drug Administration (FDA) has granted fast track designation for its lead clinical-stage program, IMM-1-104, as a treatment for patients with unresectable or metastatic NRAS-mutant melanoma who have progressed on or are intolerant to PD-1/PD-L1-based immune checkpoint inhibitors.
FDA Observes Serious Liver Injury After Treatment with Ocaliva
FDA identified cases of serious liver injury among patients being treated for primary biliary cholangitis with Ocaliva who did not have cirrhosis of the liver.
Trial Shows Experimental Cancer Drug Helped Reduce Risk of Death in Common Blood Cancer
Results of a trial of GSK’s experimental cancer drug Blenrep showed that the drug used in combination with other treatments reduced the risk of death by 42 percent in multiple myeloma, at or after first relapse, compared to an existing treatment.
FDA Approves YESINTEK to Treat Autoimmune Diseases
Biocon Biologics has received U.S. Food and Drug Administration (FDA) approval for YESINTEK, a monoclonal antibody for the treatment of autoimmune conditions, including Crohn’s disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis. Y
Pfizer’s RSV Vaccine ABRYSVO Approved by FDA
The U.S. Food and Drug Administration (FDA) has approved ABRYSVO (respiratory syncytial virus vaccine [RSV]), a bivalent RSV prefusion F (RSVpreF) vaccine, for the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV.
FDA Approves New Treatment for Hemophelia A and B
The U.S. Food and Drug Administration (FDA) approved Hympavzi (marstacimab-hncq) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A without factor VIII inhibitors or hemophilia B without factor IX inhibitors (neutralizing antibodies).
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.
Addition of IVIG May Be Superior to Addition of Plasmapheresis in Corticosteroid-Resistant Optic Neuritis: Systemic Review
A meta-analysis and systematic review compared the efficacy of corticosteroids (CS) alone against CS combined with intravenous immune globulin (IVIG) or CS combined with plasmapheresis (PP) in patients with steroid-resistant optic neuritis.
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.
Scientists Develop $25 Nasal Spray That Is 99% Effective Against Colds, Flu and COVID-19
Scientists at Harvard Medical School have developed a simple nasal spray, made of harmless ingredients, that can protect people against flu, colds and COVID-19 with near-100 percent success, and it costs just $25.
