FDA Grants Additional Indication for Darzalex Faspro Combo in Frontline Myeloma
On Jan. 27, 2026, the US Food and Drug Administration (FDA) approved Johnson & Johnson’s Darzalex Faspro® (daratumumab and hyaluronidase‑fihj) in combination with bortezomib, lenalidomide, and dexamethasone (D‑VRd) for the treatment of adults who have newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplant (ASCT). Darzalex Faspro is a CD38-directed cytolytic antibody, and this approval represents its twelfth indication. Approval was supported by the phase III CEPHEUS trial, in which D‑VRd nearly doubled minimal residual disease (MRD) negativity rates (52.3% vs. 34.8%) and demonstrated a 40% reduction in risk of disease progression or death compared with VRd alone. The FDA noted that the regimen’s efficacy has not been established in patients who refused transplant as initial therapy. The recommended dose is 1,800mg of Darzalex Faspro and 30,000 units hyaluronidase administered subcutaneously (SC) with standard VRd dosing. Safety warnings include hypersensitivity, cardiac toxicity in light chain amyloidosis, infections, neutropenia, thrombocytopenia, embryo-fetal toxicity, and interference with blood compatibility testing. The intravenous (IV) formulation of Darzalex also holds approvals for multiple myeloma indications, including the treatment of adults with NDMM who are ineligible for ASCT. Here is the updated prescribing information.
FDA Approves Yuvezzi, Previously Brimochol PF, for Presbyopia
The FDA approved Tenpoint Therapeutics’ Yuvezzi™ (carbachol 2.75% and brimonidine tartrate 0.1%), the first dual‑agent ophthalmic solution indicated for the treatment of presbyopia in adults, on Jan. 28, 2026. Presbyopia, a gradual decline in near vision that typically begins around 45 years of age, affects an estimated 128 million people in the United States. Yuvezzi, previously known as Brimochol PF™, contains carbachol, a cholinergic agent first introduced in 1972 for cataract surgery, and brimonidine tartrate, an alpha‑adrenergic agonist marketed since 1996 for ocular hypertension and later for reducing eye redness. Together, the agents constrict the pupil to sharpen near vision and improve depth of focus. Their combined action enhances pupil selectivity and increases carbachol’s availability, providing up to 10 hours of sustained miosis (constriction of the pupil) with once‑daily dosing. Approval was supported by two phase III studies demonstrating superior near‑vision efficacy compared with each individual component and achievement of all primary binocular near‑vision endpoints. The most common side effects include headache, temporary eye pain or irritation, and mild vision effects. Yuvezzi is expected to be commercially available in the second quarter of 2026. The prescribing information is here.
AAP Releases 2026 Childhood Immunization Schedule Following CDC Revisions
On Jan. 26, 2026, the American Academy of Pediatrics (AAP) published its updated Recommended Childhood and Adolescent Immunization Schedule, reaffirming routine vaccination against 18 infectious diseases, including RSV, hepatitis A and B, rotavirus, influenza, and meningococcal disease. The update follows the Centers for Disease Control and Prevention (CDC)’s January 2026 revised childhood immunization schedule, which shifted several universal vaccine recommendations into high‑risk or shared clinical decision‑making categories. AAP officials noted that their recommendations remain consistent with the organization’s 2025 schedule, reflecting no major changes in routine vaccine guidance. The differing approaches have drawn attention from pediatric clinicians who say the revisions could affect clarity and consistency in vaccination practices. The AAP stated that its schedule continues to reflect longstanding, evidence‑based recommendations for routine pediatric immunization. The schedule, endorsed by 12 medical and health organizations, is detailed here, with a parent‑friendly version available on HealthyChildren.org.
Updated DrugWatch Document Available
The Emerging Therapeutics department has updated DrugWatch, a document that highlights near-term pipeline drugs as well as potential new generic opportunities. The DrugWatch document is attached.
Commissioner’s National Priority Voucher Program: Early Implementation Insights Issues Document Now Available
To accelerate access to important therapies for serious or rare conditions, the FDA offers several expedited pathways. In July 2025, the Streamlining Drug Approval Processes: FDA’s Rigorous Evaluation and Expedited Approval Programs Issues Document introduced the newly announced Commissioner’s National Priority Voucher (CNPV), a pilot program designed to shorten FDA review timelines for products aligned with national health priorities. With additional information, this document revisits the CNPV and examines how the program has performed in practice, highlighting emerging challenges, political sensitivities, and evidence of selected drugs. The Issues Document is attached.