7 FDA Headlines You Missed in January 2026

Welcome back to our recap of this month's news and updates from the US Food and Drug Administration (FDA)!

In January 2026, the FDA issued a series of approvals and regulatory updates spanning rare hematology, neurology, endocrinology, respiratory, and ophthalmology care. Highlights include the approval of caplacizumab-yhdp (Cablivi) for pediatric aTTP, marking the first approved therapy for children with this life-threatening disorder, and the expansion of Octapharma’s Fibryga kit to a 2-gram presentation for acquired fibrinogen deficiency, improving dosing flexibility in critical bleeding. In endocrinology, the FDA requested removal of suicidal ideation warnings from GLP-1 receptor agonist labeling after extensive safety reviews found no increased risk, while in mental health, ProlivRx became the first at-home neuromodulation therapy for adults with major depressive disorder, demonstrating improved remission rates in the MOOD trial.

Additional highlights in January 2026 include the approval of new discreet packaging for OTC Narcan to increase carry rates and readiness in opioid emergencies, 510(k) clearance of LEADOPTIK’s Last Inch Assessment™ system to enhance lung biopsy accuracy with integrated high-resolution imaging, and Tenpoint Therapeutics’ YUVEZZI, the first fixed-dose dual-agent eye drop for presbyopia, which improved near vision by ≥3 lines in pivotal trials without compromising distance acuity. Here’s a concise overview of the key FDA decisions and updates from January 2026.

Want to hear from the experts? Look for our Related Content links underneath blurbs for insight into how this decision might influence practice moving forward.

1. FDA Approves Caplacizumab-yhdp (Cablivi) as First Treatment for Pediatric aTTP

On January 5, 2026, the FDA approved Sanofi’s caplacizumab-yhdp (Cablivi) for use in pediatric patients aged ≥12 years with acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy. The decision expands caplacizumab’s 2019 adult indication and makes it the first approved therapy specifically for pediatric aTTP, a rare and life-threatening disorder. Approval was supported by data from a retrospective chart review of 30 patients aged 2–18 years, in which 80% achieved clinical remission, defined by sustained normalization of platelet counts and LDH levels.

2. FDA Approves 2-Gram Fibryga Kit for Acquired Fibrinogen Deficiency

On January 7, 2026, the FDA approved a new 2-gram presentation of Octapharma’s fibrinogen (human) lyophilized powder for reconstitution (Fibryga) for fibrinogen replacement in patients with acquired fibrinogen deficiency. The expanded presentation builds on Fibryga’s 2024 approval as the first and only virus-inactivated, plasma-derived fibrinogen concentrate approved for this indication in the US and is designed to improve dosing flexibility and speed of administration in critical bleeding settings.

3. FDA Requests Removal of Suicidal Ideation Risk From GLP-1 RA Labels

On January 13, 2026, the FDA requested the removal of language describing a potential risk of suicidal ideation and behavior from the labeling of select GLP-1 receptor agonists, including liraglutide (Saxenda), semaglutide (Wegovy), and tirzepatide (Zepbound), following a comprehensive safety review. Based on meta-analyses of more than 100,000 patients and large real-world studies, the Agency found no evidence of increased risk for suicidal ideation, self-harm, or other psychiatric adverse events associated with GLP-1 RA use.

4. FDA Approves ProlivRx, First At-Home Neuromodulation Device for MDD

The FDA has approved ProlivRx, the first at-home, physician-directed neuromodulation therapy for adults with major depressive disorder who have not responded to at least one antidepressant, enabling supervised treatment outside of clinic settings. Approval was supported by the MOOD trial, in which ProlivRx significantly improved remission rates versus sham and demonstrated a favorable safety profile, positioning it as a new nonpharmacologic option for difficult-to-treat depression.

5. FDA Approves New Narcan Packaging, Aiming to Boost Carry Rates

The FDA has approved new discreet carrying-case packaging for OTC Narcan (naloxone) nasal spray to improve portability, reduce stigma, and encourage everyday carry. The update addresses persistently low preparedness, as only 10% of the general population reports carrying naloxone despite its OTC availability.

6. FDA Clears LEADOPTIK's LIA System for Higher-Accuracy Lung Biopsy

The FDA has granted 510(k) clearance to LEADOPTIK’s Last Inch Assessment™ system, a first-of-its-kind biopsy-integrated depth imaging technology designed to improve real-time tissue confirmation during lung biopsies. By embedding high-resolution imaging directly into standard biopsy tools, the system aims to close a critical diagnostic gap and improve biopsy accuracy, reported to exceed 95% in preclinical data.

7. FDA Approves First Dual-Agent Eye Drop for Near Vision Loss

The FDA has approved Tenpoint Therapeutics’ YUVEZZI (carbachol and brimonidine tartrate ophthalmic solution 2.75%/0.1%) as the first fixed-dose, dual-agent topical therapy for presbyopia in adults, offering a non-invasive option to improve near vision. Approval was supported by phase 3 BRIO I and II trials demonstrating ≥3-line improvement in binocular uncorrected near visual acuity for up to 8 hours without significant loss of distance vision, with a favorable safety profile including low rates of ocular hyperemia.

Related: The Future of Yuvezzi Eye Drops in Presbyopia, With John Hovanesian, MD