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The "Monthly Update" Podcast from Drugs.com delivers monthly roundups of new drug approvals, updated indications, safety alerts, and the latest healthcare news.
Welcome to the April 2026 edition of Drugs.com Monthly Update, where we bring you some of 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.
In this episode, we’re exploring a diverse range of FDA approvals that are expanding the toolkit for clinicians and patients alike. Our focus today includes Foundayo, a novel oral option for weight management; Otarmeni, a pioneering gene therapy for genetic hearing loss; Idvynso, a complete two-drug regimen for HIV-1; and Langlara, the newest interchangeable biosimilar in the insulin glargine market. Whether it's simplifying a daily routine or tackling a rare genetic condition, this month’s approvals focus on making care more effective and a lot less burdensome.
Our first highlight is Foundayo, spelled F-O-U-N-D-A-Y-O. This once-daily oral GLP-1 receptor agonist was approved for chronic weight management in adults with obesity or overweight with at least one weight-related condition. In a late-stage clinical trial, participants taking the highest dose of Foundayo achieved an average body weight reduction of approximately 12% over 72 weeks compared to just 1% in the placebo group. Unlike some other oral weight-loss medications, Foundayo is taken once daily at any time, with or without food and water restrictions. Common side effects include nausea, constipation, diarrhea, vomiting, and hair loss; additionally, it may reduce the effectiveness of oral contraceptives during the initial weeks of treatment.
Moving on to a breakthrough in otology, the FDA has granted accelerated approval to Otarmeni, spelled O-T-A-R-M-E-N-I. This is an adeno-associated virus vector-based gene therapy indicated for pediatric and adult patients with severe-to-profound sensorineural hearing loss associated with variants in the OTOF gene. Clinical data demonstrated significant improvement in hearing sensitivity, as assessed by pure tone audiometry at week 24.. Otarmeni is administered as a single-dose intracochlear infusion directly into the inner ear during a surgical procedure. Side effects may include otitis media, dizziness, and procedural risks such as vertigo or meningitis. Patients should be up to date on vaccinations before treatment.
In the field of infectious disease, the FDA approved Idvynso, spelled I-D-V-Y-N-S-O. This is a once-daily, two-drug fixed-dose combination of doravirine and islatravir for the treatment of HIV-1 infection in virologically suppressed adults. In Phase 3 trials, Idvynso demonstrated non-inferior efficacy compared to standard three-drug regimens, with over 92% of participants maintaining viral suppression at week 48. It is taken as one tablet orally once daily, with or without food. Important warnings include the risk of severe skin reactions like Stevens-Johnson syndrome, and common side effects include diarrhea, fatigue, and headache.
Lastly, for patients with diabetes, the FDA approved Langlara, spelled L-A-N-G-L-A-R-A. This is a long-acting insulin glargine injection approved as an interchangeable biosimilar to Lantus for improving glycemic control in adult and pediatric patients with diabetes. The approval was based on a comprehensive clinical program confirming that Langlara has no clinically meaningful differences in efficacy and safety compared to its reference product. It is administered via subcutaneous injection once daily at the same time each day. Like other insulin products, the most common side effect is hypoglycemia, and it carries warnings regarding potential hypersensitivity reactions and hypokalemia.
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.