The 5 Most Impactful FDA Approvals of 2025

The FDA spent 2025 challenging norms. Some of these norms, such as vaccination standards and schedules and responses to 2 measles outbreaks, proved controversial; others, such as their approval of breakthrough therapies and innovative medical devices, may have a long-lasting positive impact on Americans for years to come. These 5 approvals stand up for their clinical significance, potential impact on public health, or the novel modalities they introduced to Americans for the first time.

1. An At-Home Brain Stimulation Device for Depression

In a major milestone for mental health care, the FDA approved the Flow FL-100 cranial electrotherapy stimulator device in December. This is the first at-home noninvasive device to treat moderate to severe depression in adults, available only with a prescription and as either a standalone treatment or adjunct to medication. It is designed for daily or near-daily use outside a medical setting, delivering targeted pulses of electrical stimulation to the brain.

Hai Tran, PharmD, BCPS, pharmacy director of Drug Use Policy and Stewardship at Cedars-Sinai Medical Center in Los Angeles, California, said in an interview with Pharmacy Times that the FL-100 device will "offer an alternative for people who do not really want to get into drugs." Antidepressants carry a variety of possible side effects, including weight gain, sexual dysfunction, and social stigma. "I think this particular device gives patients another option, almost control of what your therapy can be," Tran said.

The device will likely be available to American patients beginning in mid-2026, and it is not yet clear what guidelines medical payers will make regarding the FL-100's coverage and use. The out-of-pocket cost in Europe is nearly 500 euros, plus periodic patch purchases for its at-home use. Many patients will be unable to pay this price without assistance. Yet for those who dislike the adverse effects of medications or have comorbidities that complicate the treatment of depression, the FL-100 offers a welcome alternative to pharmaceutical therapy.

2. Novel Treatments for Sexually Transmitted Infections

These are 3 approvals, but together they address long-standing gaps in the prevention of and care for sexually transmitted infections (STIs). The FDA approved gepotidacin (Blujepa; GSK) and zoliflodacin (Nuzolvence; Innoviva Specialty Therapeutics) in December, both as treatments for uncomplicated urogenital gonorrhea. These oral antibiotics are the first new treatments approved for this disease in nearly 2 decades, which has become increasingly challenging to treat due to antibiotic-resistant strains.¹

The 2 medications "have a significant impact on patient care, given the increasing resistance of gonorrhea," Tran said. "Until now, therapy has been limited to one medication, ceftriaxone, to which many patients have a severe allergy."

Both medications can have adverse interactions with other medications, and gepotidacin can impact cardiac function, Tran cautioned, and strongly advised patients to let their doctors and pharmacists know all indications and medications they may have or use. "But ultimately, these 2 oral agents offer another alternative for patients," Tran said.

In June, the FDA approved lenacapavir (Yetzugo; Gilead) as the first HIV preexposure prophylaxis (PrEP) medication administered as a twice-yearly injection. It was previously approved as an HIV treatment therapy, and the expansion to prevention marks a new patient group for the drug. A phase 3 trial showed 0 infections in the lenacapavir group, an astounding achievement in a field that can rarely offer anything with 100% efficacy. By replacing daily oral dosing with semiannual injections, lenacapavir could significantly improve adherence and expand protection among Americans, where HIV risk remains disproportionate across the racial and socioeconomic spectrum.

"For individuals who are HIV-negative but [who engage in] very high-risk behavior, obviously adherence is a concern," Tran said. "So this offers another option for those individuals."

Tran also stressed that lenacapavir must be administered by a health care provider, and the cost was greater than oral medications, which would place it out of reach for some patients. Together, though, these 3 approvals have the potential to shift the STI landscape by addressing both infection rates and treatment.

3. Automated Insulin Delivery Device for Type 2 Diabetes Management

The Control-IQ technology for the t:slim X2 pump (Control-IQ+; Tandem Diabetes Care, Inc.) is not new; the combination continuous glucose monitor and insulin pump was first approved by the FDA for use in patients ages 6 and older with type 1 diabetes (T1D) in December 2019. In February 2025, the FDA expanded use of the Control-IQ+ pump for patients with type 2 diabetes (T2D).

Patients with type 2 diabetes (T2D) outnumber those with T1D nearly 20:1, but, as Tran said, "an even smaller [subset] of patients will need insulin, and an even smaller number will need a pump." But for those who do, "the Control-IQ+ is certainly going to offer a lot more for these difficult-to-treat patients," she said.²

The approval will also impact accessibility. "If the device is not approved for the indication, insurance is not going to pay for it," Tran said. "Now that [the Control-IQ+] is approved for that type, it's going to be available for more patients."

4. First-in-class Non-opioid Acute Pain Reliever

When the FDA approved suzetrigine (Journavx; Vertex Pharmaceuticals) in January, its manufacturers called it "a historic milestone for the 80 million people in America who are prescribed a medicine for moderate-to-severe acute pain each year," in a news release.³

As an oral, non-opioid, highly selective NaV1.8 pain signal inhibitor, suzetrigine represents effective pain relief without the addictive potential of opioids. According to Vertex, approximately 85,000 Americans develop an opioid use disorder after receiving a prescription opiate to treat pain each year.³ Downstream effects of this approval, therefore, may include a reduction in the burden of addiction care on the health care system and society at large, and a reduction in lives lost to opioid overdose.

Existing data include patients up to 14 days post-operation for 2 types of surgeries, and more data and transparency are needed before health care practitioners will fully understand suzetrigine's place in multimodal pain management. Still, this approval offers potential relief for patients with post-surgical pain.

5. Generic Rivaroxaban Expands Access for Cardiovascular Event Prevention

Heart disease has long been, and is still, the number 1 killer in the US. The FDA approved rivaroxaban (Xarelto; Johnson & Johnson), a factor Xa inhibitor, in 2011 as a prophylaxis for deep vein thrombosis and to reduce the risk of embolism in patients with atrial fibrillation. For the first time in March 2025, that expansion has been applied to generic versions of the drug.

"Whenever a drug is available in generic form, it always means that it is more accessible to patients and it is cheaper for patients," Tran said. It is one of the most commonly prescribed oral anticoagulants in this country and has the potential to save millions of lives, especially as emerging data shows rivaroxaban to be as effective as other, more burdensome standards of care.

"Because not all strengths are available [as] generics, it may not have as big of an impact yet. ... But I'm hoping that by next year, more strengths will be available, and that's going to really help the medication be more accessible to our patients," Tran said.

A Standard-Shifting Year

Several other approvals this year filled critical gaps in rare and hard-to-treat conditions, including Wiskott-Aldrich syndrome, IgA nephropathy, and pediatric gastrointestinal disorders. New biosimilars and oncology agents also made news in 2025, and while these affect a smaller patient population, they represent meaningful change in precision medicine and therapeutic access across a wide array of indications. Together these approvals point toward a future where health care is increasingly personalized and accessible.

REFERENCES

1. Valletti, D. FDA Approval of Zoliflodacin: A New Era in Gonorrhea Treatment. Pharmacy Times. December 17, 2025. https://www.pharmacytimes.com/view/fda-approval-of-zoliflodacin-a-new-era-in-gonorrhea-treatment

2. Bullard KM, Cowie CC, Lessem SE, et al. Prevalence of Diagnosed Diabetes in Adults by Diabetes Type — United States, 2016. MMWR Morbidity and Mortality Weekly Report. 2018;67(12):359-361. doi:https://doi.org/10.15585/mmwr.mm6712a2

3. Gallagher, A. FDA Approves Suzetrigine, New Alternative to Opioids for Acute Pain. Pharmacy Times. January 30, 2025. https://www.pharmacytimes.com/view/fda-approves-suzetrigine-new-alternative-to-opioids-for-acute-pain

4. Vertex Announces FDA Approval of Journavx (suzetrigine), a first-in-class treatment for adults with moderate-to-severe acute pain. News release. Vertex. January 30, 2025. Accessed January 30, 2025. https://news.vrtx.com/news-releases/news-release-details/vertex-announces-fda-approval-journavxtm-suzetrigine-first-class