FDA Approves Takeda’s Orzeyful to Treat Type 1 Narcolepsy
The U.S. Food and Drug Administration has approved Takeda’s Orzeyful (oveporexton) tablets to treat narcolepsy type 1 in adults.
Infants More Susceptible Than Older Children to Severe Illness from Viruses
A new study has found infants are far more vulnerable than older children to severe illness from viruses such as influenza, respiratory syncytial virus (RSV), human metapneumovirus (hMPV) and SARS-CoV-2.
FDA Approves First mRNA Influenza Vaccine
The U.S. Food and Drug Administration has approved mFLUSIVA (mRNA-1010), a new vaccine against seasonal influenza, for use in all adults 50 years and older.
Nasal DNA Vaccine Protects Against Tuberculosis
Researchers have developed an experimental therapeutic nasal DNA vaccine for tuberculosis.
New HIV Vaccine Could Protect Against Development of HIV Infection and AIDS
Scientists have developed a new HIV vaccine that has the potential to protect humans from developing HIV infection and AIDS.
BCG Vaccine Linked to Changes in Brain Immunity and Alzheimer’s Biomarkers
The Bacillus Calmette-Guérin accine may alter immune activity around the brain and change levels of a protein closely associated with Alzheimer’s disease in older adults without evidence of the condition.
First Treg Immunotherapy Approved to Improve Chronic GVHD-Free Survival in Blood Cancer Patients
FDA has approved Tregzi, the first regulatory T (Treg) cell-based immunotherapy for improving chronic graft-versus-host disease (GVHD)-free survival in adult patients with blood cancers undergoing allogeneic hematopoietic stem cell transplantation.
New Healthcare Advisory Committee Created to Improve Patient Care
The Healthcare Advisory Committee will develop actionable policy solutions, advance accountability for safety and more.
New CMS Proposal to Speed up Patient Access to Drugs
The new federal advisory body, the Healthcare Advisory Committee, will provide advice on modernizing healthcare in the U.S.
FDA Approves Gene Therapy for Rare Immune Disorder (2026)
FDA-approved Kresladi (marnetegragene autotemcel) is the first gene therapy treating leukocyte adhesion deficiency type I (LADI).