5 FDA Decisions for Primary Care to Know from June 2026

In June, the US Food and Drug Administration (FDA) issued several regulatory decisions with potential relevance across primary care, dermatology, infectious disease, and behavioral health. The updates included a first-in-class oral postexposure prophylaxis option for COVID-19, a Complete Response Letter for an investigational ADHD therapy, and clearance of a personalized neuromodulation platform for post-traumatic stress disorder.

In infectious disease, Shionogi announced FDA approval of ensitrelvir (Xocova) for postexposure prophylaxis of COVID-19 in adults and adolescents aged 12 years and older after contact with an individual with COVID-19. The approval was supported by the phase 3 SCORPIO-PEP trial, in which ensitrelvir reduced the risk of symptomatic COVID-19 by 67% through day 10 compared with placebo among uninfected household contacts.

Other actions highlighted the breadth of recent FDA activity in neuropsychiatric and dermatologic care. Cingulate received a Complete Response Letter for CTx-1301, an investigational once-daily dexmethylphenidate HCl tablet for ADHD, with the company stating that FDA requests were limited to chemistry, manufacturing, and controls information. Wave Neuroscience announced FDA clearance of its Magnetic EEG-guided Resonance Therapy system for PTSD, while AbbVie and Arcutis announced pediatric expansions for risankizumab-rzaa (Skyrizi) in psoriatic disease and roflumilast cream 0.3% (Zoryve) for plaque psoriasis in children as young as age 2, respectively.

1. FDA Approves Ensitrelvir as First Oral COVID-19 Postexposure Prophylaxis Option

On June 1, 2026, Shionogi announced FDA approval of ensitrelvir (Xocova), an oral antiviral, for postexposure prophylaxis of COVID-19 in adults and adolescents aged 12 years and older following contact with an individual with COVID-19. Based on results from the phase 3 SCORPIO-PEP trial, ensitrelvir reduced the risk of symptomatic COVID-19 by 67% through day 10 compared with placebo among uninfected household contacts. The 5-day regimen was generally well tolerated, with adverse event rates similar to placebo. Ensitrelvir is the first oral option approved in the US to help prevent COVID-19 after exposure and is not approved for COVID-19 treatment in the US.

2. FDA Issues Complete Response Letter for Cingulate ADHD Drug CTx-1301

On June 2, 2026, Cingulate announced it had received a Complete Response Letter from the FDA for CTx-1301, an investigational once-daily dexmethylphenidate HCl tablet for the treatment of ADHD. Based on the FDA’s response, the outstanding issues were limited to chemistry, manufacturing, and controls information requests, with no current concerns identified related to clinical safety or efficacy. CTx-1301 uses Cingulate’s Precision Timed Release platform, designed to deliver 3 timed releases of medication throughout the day to support rapid onset and active-day symptom coverage. The company stated it expects to address the FDA’s requests quickly and pursue resubmission.

3. FDA Clears Wave Neuroscience MeRT System for PTSD

On June 10, 2026, Wave Neuroscience announced FDA clearance of its Magnetic EEG-guided Resonance Therapy (MeRT) system for post-traumatic stress disorder. Based on a double-blind, randomized, controlled, multisite clinical study, the company said MeRT was associated with significant and clinically meaningful reductions in PTSD symptom severity. MeRT is a noninvasive neuromodulation system that uses EEG-based brain activity analysis, including AI-augmented biomarker assessment, to inform individualized stimulation protocols. However, Wave Neuroscience did not report key clinical trial details, including sample size, primary endpoint, magnitude of effect, durability, or adverse event rates.

4. FDA Approves Risankizumab for Pediatric Psoriasis, Psoriatic Arthritis

On June 26, 2026, AbbVie announced FDA approval of risankizumab-rzaa (Skyrizi) for children aged 6 years or older with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, or with active psoriatic arthritis. Based on data from the phase 3 OptIMMize psoriasis clinical trial program, risankizumab was associated with clinically meaningful improvements in static Physician Global Assessment and Psoriasis Area and Severity Index responses at week 16, with responses maintained during continued treatment. The pediatric psoriatic arthritis indication was supported by OptIMMize and population pharmacokinetic modeling and simulation using adult psoriatic arthritis data. The approval also adds a 55-mg prefilled syringe to support weight-based dosing in pediatric patients weighing less than 40 kg.

5. FDA Expands Roflumilast Cream 0.3% Approval for Plaque Psoriasis in Children Aged 2 Years and Older

On June 29, 2026, Arcutis announced FDA approval of a supplemental New Drug Application expanding roflumilast cream 0.3% (Zoryve) for topical treatment of plaque psoriasis, including intertriginous areas, in children aged 2 years and older. Based on a 4-week Maximal Usage Systemic Exposure study in children aged 2 to 5 years and supportive long-term safety data from an open-label extension study, the safety and efficacy profiles were generally consistent with prior pivotal trial findings in adolescents and adults. The approval makes roflumilast cream 0.3% the first once-daily, steroid-free topical therapy approved for plaque psoriasis in children as young as age 2, according to Arcutis. Zoryve is contraindicated in patients with moderate to severe liver impairment and is for topical use only.