The Drugs.com Monthly Update Podcast

Welcome to the January 2026 edition of Drugs.com Monthly Update, the podcast that keeps you informed about the latest FDA approvals. This episode uses AI tools to help with formatting, organisation, and narration. All content has been reviewed by a senior editorial pharmacist.

This month, we'll delve into the latest approvals from the FDA, including a new indication for Darzalex Faspro for multiple myeloma, a new combination eye drop called Yuvezzi for presbyopia, Zycubo for Menkes disease, and the extended use of the Nexplanon birth control implant. We'll also touch on other significant updates in various therapeutic areas.

Let's begin with an important development for multiple myeloma patients. The FDA has approved Darzalex Faspro, spelled D-A-R-Z-A-L-E-X F-A-S-P-R-O, in combination with bortezomib, lenalidomide, and dexamethasone for adults newly diagnosed with multiple myeloma who are ineligible for a stem cell transplant. Multiple myeloma is a cancer of plasma cells in the bone marrow that can cause bone pain, fractures, kidney problems, and anemia. Darzalex Faspro is the only subcutaneous CD38-directed antibody approved for multiple myeloma. It combines daratumumab with hyaluronidase, allowing it to be given as a quick injection under the skin instead of a lengthy IV infusion. In patients ineligible for stem cell transplant, studies showed that adding Darzalex Faspro to standard treatment (bortezomib, lenalidomide, and dexamethasone) significantly improved how long patients responded to therapy compared to standard treatment alone. Common side effects include respiratory infections, nerve pain or numbness, and musculoskeletal pain.

Shifting our focus to ophthalmology, the FDA has approved Yuvezzi, spelled Y-U-V-E-Z-Z-I, as the first FDA-approved dual-agent eye drop for presbyopia. Presbyopia is the gradual loss of near vision that typically begins around age 45. Yuvezzi combines carbachol and brimonidine tartrate, two well-established agents for presbyopia, and is given as one drop in each eye once daily. Phase 3 trials showed the combination worked better than each ingredient alone. One drop sharpens vision within 30 minutes and lasts up to 10 hours. Users should be wary of potential side effects, such as blurred vision or eye irritation, and exercise caution during hazardous activities in poor lighting.

In pediatric care, the FDA has announced its approval of Zycubo, spelled Z-Y-C-U-B-O. This medication is the first treatment for Menkes disease, a rare genetic disorder affecting copper transport. This disorder leads to severe developmental delays and early death, usually before age 3. Zycubo's subcutaneous copper histidinate formulation delivers copper into the bloodstream, bypassing intestinal absorption issues. Clinical trials showed a 78% reduced risk of death when started within 4 weeks of birth. Important precautions include possible copper accumulation and related toxicities.

Turning to women's health, Nexplanon, spelled N-E-X-P-L-A-N-O-N, now has FDA approval for extended use for up to five years. This progestin-based birth control implant is inserted under the skin of the upper arm. Recent studies confirmed its effectiveness across different body weights with no new safety concerns. However, due to risks from improper insertion or removal, the FDA now requires a REMS program. Starting February 23, 2026, US providers must enroll in this program within six months to continue offering Nexplanon.

Lastly, let's discuss updates involving Afrezza, spelled A-F-R-E-Z-Z-A, an inhalable insulin for diabetes management. The FDA has approved a label update facilitating a simpler dose conversion from injected insulin. Afrezza offers quick blood sugar control through inhalation, presenting a convenient option for adults with diabetes. Not suited for individuals with chronic lung issues, and users should be aware of potential side effects like hypoglycemia or throat irritation.

Thank you for tuning in to the Drugs.com monthly update podcast, where staying informed means staying ahead in your field. We look forward to bringing you more updates next month.

Until next time, know more, be sure.