FluMist is a vaccine in the form of a nasal spray approved for the prevention of influenza disease caused by influenza virus subtypes A and B in individuals two through 49 years of age. In 2024, the FDA approved it for self- or caregiver-administration.
Dupixent (dupilumab) is an interleukin-4 receptor alpha antagonist used for the treatment of atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, prurigo nodularis, and chronic obstructive pulmonary disease (COPD).
Unloxcyt (cosibelimab-ipdl) is a programmed death ligand-1 (PD-L1) blocking antibody used for the treatment of cutaneous squamous cell carcinoma.
Sources: (FDA) (Fox News) (Drugs.com) (Fierce Pharma)
See also: How do medicines get their names?
Wegovy is the first FDA-approved weight-management medicine that lowers the risk of major cardiovascular events in adults with obesity and known heart disease.
Capvaxive is a vaccine for individuals 18 years of age and older to help protect against invasive pneumococcal disease and pneumonia caused by certain types of bacteria called pneumococcus.
Alhemo (concizumab-mtci) is a tissue factor pathway inhibitor (TFPI) antagonist indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with hemophilia A or B with inhibitors.
Wakix is a prescription medicine used to treat excessive daytime sleepiness (EDS) or cataplexy in adults with narcolepsy. It is also approved for treating excessive daytime sleepiness (EDS) in children six years of age and older with narcolepsy.
mResvia is a vaccine for protecting against lower respiratory tract disease (diseases of the lungs such as bronchitis or pneumonia) caused by respiratory syncytial virus (RSV) in adults aged 60 years and older.
Ohtuvayre is an inhaled, steroid-free suspension that may be used as maintenance treatment for chronic obstructive pulmonary disease (COPD) in adults. It can improve symptoms and reduce the number of flare-ups.
Aucatzyl is used for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
Revuforj is a first-in-class menin inhibitor indicated for the treatment of relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation in adult and pediatric patients of one year and older.
Alyftrek (deutivacaftor, tezacaftor and vanzacaftor) is a next-in-class, triple combination cystic fibrosis transmembrane conductance regulator (CFTR) modulator for use in the treatment of cystic fibrosis.
Attruby (acoramidis) is a transthyretin stabilizer indicated for the treatment of the cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis in adults to reduce cardiovascular death and cardiovascular-related hospitalization.
Nexletol (generic name: bempedoic acid) is an oral medication used to lower LDL (bad) cholesterol levels in adults with high cholesterol. It is particularly beneficial for those who cannot tolerate statins or need additional cholesterol-lowering treatment.
Yorvipath is a hormone replacement medicine for treating adults with chronic hypoparathyroidism.
Tryvio (generic name: aprocitentan) is a once-daily medication, a dual oral endothelin receptor antagonist (ERA), used to treat high blood pressure that is not adequately controlled by other antihypertensive medications.
Kisunla is for adults with early symptomatic Alzheimer's disease, which includes the mild cognitive impairment or mild dementia stage of the disease.
Zunveyl is approved by the US Food and Drug Administration (FDA) as a cholinesterase inhibitor indicated for the treatment of mild to moderate dementia of the Alzheimer's type in adults.
Yesintek (ustekinumab-kfce) is a human interleukin-12 and -23 antagonist biosimilar to Stelara used for the treatment of plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.
Amtagvi (lifileucel) is the first cellular therapy for treating adult patients with a type of skin cancer (melanoma) that is unable to be removed with surgery (unresectable) or has spread to other parts of the body (metastatic) that previously has been treated with other therapies.
Kebilidi (eladocagene exuparvovec-tneq) is a gene replacement therapy for use in the treatment of aromatic L-amino acid decarboxylase (AADC) deficiency.
Xolair is the first FDA-approved medication to reduce allergic reactions to more than one type of food after accidental exposure. Xolair was originally approved in 2003 for the treatment of moderate to severe persistent allergic asthma in certain patients. Xolair is also approved to treat chronic spontaneous urticaria and chronic rhinosinusitis with nasal polyps in certain patients.
Winrevair is a medicine used to improve the ability to exercise in adults with pulmonary arterial hypertension (PAH).
Neffy is the first and only needle-free epinephrine nasal spray for adults and children weighing 66 lbs or more. It claims to be the only medication proven to stop a potentially life-threatening allergic reaction.
Steqeyma (ustekinumab-stba) is a human interleukin-12 and -23 antagonist biosimilar to Stelara used for the treatment of plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.
Suzetrigine is the first new painkiller approved in the US since Celebrex, which was approved in 1998. It comes as a 50-milligram prescription pill taken every 12 hours after a larger first dose, and will be sold under the brand name Journavx.
These transformative therapies not only address critical health challenges but also exemplify the rapid progress in pharmaceutical science. To explore the full list of recently FDA-approved drugs, click through this gallery.
FDA approved: New medications and vaccines
Groundbreaking new drugs leading medical advances
HEALTH Medication
The year 2025 began with groundbreaking news for millions of Americans, following a landmark 2024 that introduced a wave of innovative medical treatments poised to reshape patient care. Among the highlights are groundbreaking drugs such as Tryvio, for managing high blood pressure, and Neffy, a needle-free epinephrine nasal spray designed to address severe allergic reactions swiftly. Alzheimer's patients have new hope with Kisunla and Zunveyl, which target the disease in unprecedented ways, while Dupixent offers a breakthrough in managing chronic obstructive pulmonary disease, improving lung function and enhancing quality of life.
These transformative therapies not only address critical health challenges but also exemplify the rapid progress in pharmaceutical science. To explore the full list of recently FDA-approved drugs, click through this gallery.