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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 July 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.
This month, we discuss several significant FDA approvals that offer new options across reproductive health, ophthalmology, psychiatry, oncology, pain management and cardiology. We're touching on Gwyn Lo as a new once-weekly low-dose contraceptive patch, Lytenava as the first approved ophthalmic formulation of bevacizumab for wet age-related macular degeneration, Simtriyo as a triple reuptake inhibitor for ADHD, Jideytro for previously treated ROS1-positive non-small cell lung cancer, and Lipfendra as the first oral PCSK9 inhibitor for high cholesterol. There’s also a new over-the-counter combination pain relief tablet: Tylenol plus naproxen.
Let's start with Gwyn Lo, spelled G-W-Y-N L-O. This once-weekly patch system, containing ethinyl estradiol and norelgestromin, was approved to prevent pregnancy in women with a BMI under 30 kg/m² for whom a combined hormonal contraceptive is appropriate. In the Phase 3 Luminous study, just 4 in 100 women became pregnant over a year, and the patches adhered well, only fully detaching 1.3% of the time. It's applied to the upper outer arm, abdomen, buttock, or back once weekly for three weeks, followed by a patch-free week. One key caution: Gwyn Lo carries a Boxed Warning. It's not for women over 35 who smoke, given the risk of serious cardiovascular events, or for those with a BMI of 30 or higher, due to a higher risk of blood clots. The most common side effects are application-site irritation, irregular bleeding, and nausea.
Next, in ophthalmology, the FDA approved Lytenava, spelled L-Y-T-E-N-A-V-A, to treat neovascular, or wet, age-related macular degeneration. In the Phase 3 NORSE TWO trial, 41.7% of patients treated with Lytenava gained at least 15 vision letters — about three lines on an eye chart — by month 11, versus 23.1% of those on the established treatment ranibizumab. It's given by a qualified physician as an injection into the eye, once every 28 days. Clinicians should watch for endophthalmitis, a serious infection inside the eye, along with retinal detachment and temporary rises in intraocular pressure, the fluid pressure within the eye. The most common adverse reactions are conjunctival hemorrhage, a harmless-looking broken blood vessel on the white of the eye, plus eye pain and vitreous floaters — small specks that drift across your vision.
Moving to psychiatry, the FDA cleared Simtriyo, spelled S-I-M-T-R-I-Y-O, to treat ADHD in adults and children aged 6 and older weighing at least 20 kg. It contains centanafadine, a first-in-class reuptake inhibitor that acts on three brain chemicals — norepinephrine, dopamine, and serotonin. Across four Phase 3 trials, Simtriyo significantly improved ADHD rating-scale scores versus placebo as early as Week 1. It's taken once daily as an extended-release capsule, swallowed whole or opened and sprinkled onto applesauce, yogurt, or orange juice. It carries a Boxed Warning for suicidal thoughts and behaviors in children aged 6 to 12, and for the potential for abuse and misuse. Common side effects include decreased appetite, headache, insomnia, nausea, dry mouth, and rash.
In oncology, the FDA approved Jideytro, spelled J-I-D-E-Y-T-R-O, giving adults with ROS1-positive non-small cell lung cancer a new option after a prior ROS1 inhibitor has stopped working. In the ARROS-1 trial, 44% of these previously treated patients responded, with responses often lasting — including in those with brain metastases or resistance mutations, two situations that have been hard to treat. What sets Jideytro apart is its precision: it's highly selective for ROS1, reaches into the brain, and covers a broad range of resistance mutations. It's an oral tablet taken once daily. Key warnings include central nervous system effects, QTc prolongation, interstitial lung disease, and bone fractures; common side effects include swelling, peripheral neuropathy, constipation, fatigue, and shortness of breath.
For heart health, the FDA approved Lipfendra, spelled L-I-P-F-E-N-D-R-A, a once-daily pill that lowers "bad" LDL cholesterol in adults with high cholesterol, including the inherited form. Alongside diet and exercise, it cut LDL by 56% to 59% versus placebo in its Phase 3 trials. You take one 20 mg tablet each morning on an empty stomach — with water, black coffee, or plain tea — then wait at least 30 minutes before eating or drinking anything else. In studies, side effects were generally on par with placebo, with diarrhea and dizziness reported a bit more often in people with the inherited form.
And finally, here's one from the pharmacy aisle: the FDA has approved Tylenol with Naproxen, the first over-the-counter tablet to combine two familiar pain relievers — acetaminophen and naproxen sodium — in a single pill. The combination works well together: acetaminophen kicks in fast, within about 30 minutes, while naproxen, an anti-inflammatory, keeps working across a full 12 hours, so you take it just twice a day. Neither ingredient is an opioid. One important reminder — don't double up by taking other acetaminophen or NSAID products alongside it, since that raises the risk of liver damage or stomach bleeding.
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.