FDA Fast Tracks Immunotherapy for HER2-Positive Breast Cancer Recurrence
The U.S. Food and Drug Administration has granted fast track designation for Greenwich LifeSciences’ lead immunotherapy candidate GLSI-100 in HLA-A*02–positive, HER2-positive breast cancer patients who have completed standard HER2-targeted therapy.
IVIG Reduces Infections Following BsAB Therapies in Multiple Myeloma Patients
A recent study showed treatment with intravenous immune globulin following infection from BCMA therapies yielded a 67 percent decrease in infections in patients with multiple myeloma.
FDA Approves Merck’s KEYTRUDA QLEX for Solid Tumor Indications
The U.S. Food and Drug Administration has approved KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph) injection for subcutaneous administration in adults across most solid tumor indications for KEYTRUDA (pembrolizumab).
States Issue Their Own Guidance About COVID-19 Vaccines
Since the U.S. Food and Drug Administration released its 2025-2026 formula approvals on Aug. 2, significantly restricting who can access the vaccines for the first time since their release, several states have issued their own guidance about COVID-19 vaccines.
Study Shows Pfizer’s Updated mRNA COVID-19 Vaccine Elicits Strong Immune Response
Pfizer and BioNTech updated mRNA COVID-19 vaccine for the 2025-2026 season produced strong immune responses, boosting neutralizing antibody levels by at least fourfold in older people and those with underlying medical conditions.
Merck’s Pneumococcal Vaccine Elicits Immune Responses to 21 Serotypes in Children with one or More Health Conditions
Positive results from Merck’s Phase III STRIDE-13 trial for its Capvaxive vaccine, a pneumococcal 21-valent conjugate vaccine show it has the potential to provide additional protection in individuals 2 through 17 years old.
FDA Expands Approval for Recombinant VWF
The U.S. Food and Drug Administration has expanded the approval of recombinant von Willebrand factor, marketed as Vonvendi.
FDA Approves LEQEMBI IQLIK to Treat Early Alzheimer’s Disease
The U.S. Food and Drug Administration (FDA) has approved the biologics license application for once weekly lecanemab-irmb subcutaneous injection (LEQEMBI IQLIK, pronounced “I Click”) for maintenance dosing.
New Documentary Gives Women with Hemophilia a Voice
A new documentary film titled “Dismissed,” which was premiered at the National Bleeding Disorders Foundation’s Bleeding Disorders Conference in Aurora, Colo., features the lived experiences of five women with hemophilia.
FDA Approves First BTK Inhibitor for ITP
The U.S. Food and Drug Administration has approved Sanofi’s Wayrilz (rilzabrutinib) for adults with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.