FDA approved: New medications and vaccines

Suzetrigine - The United States Food and Drug Administration (FDA) approved the first new type of pain reliever in 25 years this January 30.
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.

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Dupixent -

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).

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Amtagvi -

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.

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Xolair -

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.

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Wegovy -

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.

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Tryvio -

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.

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Nexletol -

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.

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Winrevair -

Winrevair is a medicine used to improve the ability to exercise in adults with pulmonary arterial hypertension (PAH).

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mResvia -

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.

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Capvaxive -

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.

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Wakix -

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.

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Ohtuvayre -

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.

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Kisunla -

Kisunla is for adults with early symptomatic Alzheimer's disease, which includes the mild cognitive impairment or mild dementia stage of the disease.

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Zunveyl -

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.

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Yorvipath -

Yorvipath is a hormone replacement medicine for treating adults with chronic hypoparathyroidism.

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Neffy -

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.

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FluMist -

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.

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Cobenfy - Cobenfy is an oral prescription medicine used to treat adults with schizophrenia.

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Yesintek -

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.

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Aucatzyl -

Aucatzyl is used for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.

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Kebilidi -

Kebilidi (eladocagene exuparvovec-tneq) is a gene replacement therapy for use in the treatment of aromatic L-amino acid decarboxylase (AADC) deficiency.

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Revuforj -

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.

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Ziihera - Ziihera (zanidatamab-hrii) is a bispecific HER2-directed antibody for the treatment of HER2-positive biliary tract cancer.

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Attruby -

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.

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Opdivo Qvantig - Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) is a programmed death receptor-1 (PD-1)-blocking antibody and hyaluronidase combination for use in the treatment of renal cell carcinoma, melanoma, non-small cell lung cancer, squamous cell carcinoma of the head and neck, urothelial carcinoma, colorectal cancer, hepatocellular carcinoma, esophageal cancer, gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma.

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Alhemo -

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.

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Steqeyma -

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.

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Alyftrek -

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.

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Unloxcyt -

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)

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Dupixent -

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Amtagvi -

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Xolair -

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Wegovy -

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.

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Tryvio -

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Nexletol -

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Winrevair -

Winrevair is a medicine used to improve the ability to exercise in adults with pulmonary arterial hypertension (PAH).

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mResvia -

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Capvaxive -

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.

Shutterstock

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Wakix -

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Ohtuvayre -

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Kisunla -

Kisunla is for adults with early symptomatic Alzheimer's disease, which includes the mild cognitive impairment or mild dementia stage of the disease.

Getty Images

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Zunveyl -

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.

Shutterstock

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Yorvipath -

Yorvipath is a hormone replacement medicine for treating adults with chronic hypoparathyroidism.

Shutterstock

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Neffy -

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FluMist -

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Cobenfy - Cobenfy is an oral prescription medicine used to treat adults with schizophrenia.

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Yesintek -

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Aucatzyl -

Aucatzyl is used for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.

Shutterstock

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Kebilidi -

Kebilidi (eladocagene exuparvovec-tneq) is a gene replacement therapy for use in the treatment of aromatic L-amino acid decarboxylase (AADC) deficiency.

Shutterstock

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Revuforj -

Shutterstock

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Ziihera - Ziihera (zanidatamab-hrii) is a bispecific HER2-directed antibody for the treatment of HER2-positive biliary tract cancer.

Shutterstock

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Attruby -

Shutterstock

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Alhemo -

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Steqeyma -

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Alyftrek -

Shutterstock

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Unloxcyt -

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)

Getty Images

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FDA approved: New medications and vaccines

Groundbreaking new drugs leading medical advances

11/03/25 | StarsInsider

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.