7 Drugs Approved for Primary Care: Q3 2025
Catch up on the 7 FDA drug approvals from Q3 2025 most relevant to primary care, including new treatments for cardiometabolic, infectious, and inflammatory diseases.
Hypertension: Ramipril (Vostally) oral solution, is an oral solution formulation of the approved angiotensin converting enzyme (ACE) inhibitor ramipril used for the treatment of hypertension in adults, to lower blood pressure. Additionally, in patients 55 years or older at high risk of developing a major cardiovascular event, ramipril is indicated to reduce the risk of myocardial infarction, stroke, or death from cardiovascular causes. Also, in adult patients with post-myocardial infarction heart failure, ramipril is indicated to reduce the risk of cardiovascular death and hospitalization for heart failure. (Approved 07/23/2025, Rosemont Pharmaceuticals Inc.)
Chronic Hand Eczema (CHE): Delgocitinib (Anzupgo) topical cream 20 mg/g, is a topical pan-Janus kinase (JAK) inhibitor for the treatment of CHE in adults who have had an inadequate response to, or for whom topical corticosteroids are not advisable. This approval makes delgocitinib the first treatment specifically indicated by the FDA for CHE, a condition that affects approximately 1 in 10 adults worldwide. (Approved 07/23/2025, Leo Pharma AS)
Chronic spontaneous urticaria (CSU): Remibrutinib (Rhapsido) tablets, the first oral Bruton’s tyrosine kinase inhibitor (BTKi) for adults with CSU who remain symptomatic despite H1-antihistamine treatment. (Approved 09/30/2025, Novartis)
Acromegaly: Paltusotine (Palsonify™) tablets, a somatostatin receptor agonist indicated for the treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option. Paltusotine is the first once-daily oral treatment for acromegaly in adults. (Approved 09/25/2025, Crinetics Pharmaceuticals)
Diabetes mellitus: Insulin aspart-xjhz (Kirsty) injection, 100 units/mL, a rapid-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. It is the first and only interchangeable biosimilar to Insulin Aspart (NovoLog®). (Approved 07/15/2025, Biocon Biologics Inc.)
Bronchiectasis: Brensocatib (Brinsupri™) tablets, 10 mg and 25 mg, a first-in-class dipeptidyl peptidase 1 (DPP1) inhibitor indicated for the treatment of non-cystic fibrosis bronchiectasis in adult and pediatric patients 12 years of age and older. (Approved 08/12/2025, Insmed Incorporated)
Fibromyalgia: Cyclobenzaprine hydrochloride (Tonmya), formerly TNX-102 SL, a sublingual formulation of cyclobenzaprine hydrochloride indicated for the treatment of fibromyalgia in adults. (Approved 08/15/2025, Tonix Pharmaceuticals Holding Corp.)
The US FDA approved several new medications during the third quarter of 2025 that are likely to impact daily practice in primary care. From novel treatments targeting metabolic and cardiovascular diseases to therapies addressing infectious, inflammatory, and respiratory conditions, these approvals expand the options available for clinicians managing common and complex disorders alike. In the slideshow above, find 7 key FDA approvals from July through September 2025 that primary care physicians should be aware of.
