In 2025, the FDA approved 46 novel drugs, with many more gaining approval for expanded indications, generic formulations, and biosimilars. While the number of novel drug approvals dipped slightly below the 55 approvals in 2023 and 50 approvals in 2024, the steady progress provides medical therapies and innovation to meet unmet need for patient care.
As we look forward to 2026, here’s a recap of some impactful FDA drug approvals from 2025 and what their availability may mean in 2026 and beyond.
Brensocatib, a reversible dipeptidyl peptidase 1 (DPP1) inhibitor, is now approved for the treatment of non-cystic fibrosis bronchiectasis in patients 12 years and older. Brensocatib is the first FDA-approved medication for non-cystic fibrosis bronchiectasis, with the ASPEN and WILLOW trials showing reduced risk of pulmonary exacerbation.
Bumetanide nasal spray, a new formulation of the available loop diuretic that is not intended for chronic use, was approved for edema associated with heart failure and hepatic and renal disease. With less absorption variability than the oral formulation, the nasal spray introduces the potential for more patients to treat fluid overload at home to avoid hospitalization.
Clesrovimab, a respiratory syncytial virus (RSV) F protein-directed fusion inhibitor, is now approved for the prevention of RSV lower respiratory tract disease in neonates and infants who are born during or entering their first RSV season. Clesrovimab joins nirsevimab in the line-up of RSV prophylactic antibodies for infants, improving drug access and mitigating potential drug shortages (previously seen with nirsevimab in RSV season 2023-2024).
Elinzanetant, a nonhormonal neurokinin 1 and 3 antagonist, was approved for treatment of moderate-to-severe vasomotor symptoms due to menopause. Elinzanetant joins fezolinetant in the lineup of neurokinin 1 antagonists for burdensome vasomotor symptoms, providing an additional nonhormonal option for patients who cannot or choose not to take hormonal therapy.
Etripamil, a calcium channel blocker, is now approved for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (SVT) to sinus rhythm in adults intended for use in the outpatient setting. Current strategies for outpatient cessation of SVT include single-dose oral treatment, or “pill-in-the-pocket” strategy with an antiarrhythmic drug (such as beta blockers, calcium channel blockers, or flecainide). Etripamil is a nasal spray formulation that has rapid absorption, adding another quick and easy option for select patients who have infrequent but prolonged SVT episodes.
Lenacapavir, an HIV-1 capsid inhibitor, was approved as a twice-yearly HIV PrEP (preexposure prophylaxis regimen for prevention) in adults and adolescents weighing at least 35 kg who are at risk of exposure. The twice-yearly IV dosing offers a distinct advantage for patients challenged by adherence to daily/frequent regimens, stigma, and barriers to healthcare access.
Pembrolizumab/Berahyaluronidase, a subcutaneous formulation of pembrolizumab, is now FDA approved, enabling easier administration of pembrolizumab injection for a variety of solid tumor indications.
Semaglutide, a GLP-1 agonist, received some additional notable approvals in 2025, including accelerated approval for treatment of noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver fibrosis in adults as well as for use in adults with type 2 diabetes (injectable formulation). A new oral semaglutide formulation was also approved for weight loss in adults with obesity or those who are overweight with a comorbid condition and for risk reduction of major adverse cardiovascular events in adults.
Suzetrigine, a nonopioid analgesic that works via selective sodium channel inhibition, was approved for treatment of moderate or severe acute pain in adults. Notably, suzetrigine was primarily studied for acute postoperative pain and it’s unclear how it may be used for other pain management indications. It’s novel mechanism of action as a nonopioid analgesic is promising in the potential mitigation of risks associated with opioid analgesics for acute pain management.
Tradipitant, a substance P/neurokinin-1 (NK-1) receptor antagonist, is now approved for the prevention of vomiting induced by motion sickness in adults, marking the first novel treatment for motion sickness in over four decades.
There are several highly anticipated drug approvals set for FDA review in 2026, such as expanded use for inhaled insulin to pediatric patients, new uses for GLP-1 agonists, and a novel sublingual epinephrine formulation. At DynaMed, our editorial team monitors new drug approvals from the FDA and other regulatory authorities to ensure that new drug approvals are incorporated into DynaMed to represent the latest therapies. You can rest assure that DynaMed will keep you informed about the latest drug approvals in a timely and clear manner.
