The FDA approved Itvisma, the first gene replacement therapy for children 2 years and older, teens, and adults with spinal muscular atrophy, a one-time treatment that replaces the SMN1 gene and demonstrated improved motor function in Phase 3 studies.
Experts counter Robert F. Kennedy Jr.’s claims about aluminum adjuvant safety, noting extensive evidence that aluminum-containing vaccines remain effective and well-validated.
A patient with advanced head-and-neck cancer regained functional communication using an AI-generated voice clone after total glossectomy and laryngectomy.
The FDA’s authorization of the Q-Collar is under scrutiny after researchers identified duplicated data, altered study endpoints, and unsubstantiated “brain protection” claims.