New Drugs

Brand/Generic Company Description
Alymsys
bevacizumab-maly
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Amneal Pharm.

A new biosimilar to Avastin.

Amvuttra
vutrisiran
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Alnylam

A double-stranded siRNA-GaINAc conjugate for polyneuropathy of hereditary transthyretin-mediated amyloidosis.

Camzyos
mavacamten
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Bristol-Myers Squibb

A cardiac myosin inhibitor for obstructive hypertrophic cardiomyopathy.

Cibinqo
abrocitinib
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Pfizer

A Janus kinase inhibitor for refractory, moderate to severe atopic dermatitis.

Cimerli
ranibizumab-eqrn
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Coherus BioSciences

A new biosimilar to Lucentis.

Enjaymo
sutimlimab-jome
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Bioverativ USA

A monoclonal antibody for patients with cold agglutinin disease.

Fylnetra
Pegfilgrastim-pbbk
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Amneal Pharm.

A new biosimilar to Neulasta.

Kimmtrak
tebentafusp-tebn
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Immunocore

A CD3 T cell engager for advanced uveal melanoma.

Mounjaro
tirzepatide
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Eli Lilly

A glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist for type 2 diabetes.

Opdualag
nivolumab/relatlimab-rmbw
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Bristol-Myers Squibb

A combination monoclonal antibody for unresectable or metastatic melanoma.

Pluvicto
lutetium Lu 177 vipivotide tetraxetan
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Novartis

A radioligand agent for advanced prostate cancer.

Priorix
measles, mumps, and rubella vaccine
GlaxoSmithKline

A new live vaccine to prevent measles, mumps, and rubella.

Pyrukynd
mitapivat
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Agios Pharm.

A pyruvate kinase activator for hemolytic anemia in adults with pyruvate kinase deficiency.

Quviviq
daridorexant
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Idorsia Pharm.

An orexin receptor antagonist for insomnia.

Releuko
filgrastim-ayow
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Amneal Biosciences

A biosimilar to Neupogen.

SpikeVax
Covid-19 vaccine, mRNA
Moderna

A vaccine to prevent COVID-19 infection in patients 18 years of age and older.

Tyvaso
treprostinil
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United Therapeutics

A prostacyclin analogue for pulmonary hypertension.

Vabysmo
faricimab-svoa
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Genentech

An intravitreal injection for age-related macular degeneration and diabetes-associated macular edema.

Vivjoa
oteseconazole
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Mycovia Pharm

An azole antifungal for vulvovaginal candidiasis.

Vonjo
pacritinib
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CTI BioPharma

A kinase inhibitor for myelofibrosis.

Voquezna
vonoprazan
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Phathom Pharma

A potassium-competitive acid blocker co-packaged with amoxicillin (Dual Pak) or amoxicillin and clarithromycin (Triple Pak) for Helicobacter pylori.

Vtama
tapinarof
Dermavant Sciences

A topical steroid-free aryl hydrocarbon receptor agonist for plaque psoriasis.

Ztalmy
ganaxolone
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Marinus Pharm.

An antiseizure medication for patients with cyclin-dependent kinase-like 5 deficiency disorder.

Brand/Generic Company Description
Adlarity
donepezil
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Corium

New transdermal patch formulation for Alzheimer’s dementia.

Aspruzyo Sprinkle
ranolazine
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Sun Pharm.

New extended-release granule formulation for chronic angina.

bortezomib
bortezomib
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Maia Pharmaceuticals

A new injectable solution for multiple myeloma and mantle cell lymphoma.

Dapzura RT
daptomycin
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Baxter Healthcare

New formulation injectable antibiotic.

Drospirenone
drospirenone
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Exeltis USA

New chewable tablet progestin-only oral contraceptive.

Epsolay
benzoyl peroxide
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Sol-Gel Technologies

New topical cream formulation for rosacea.

Fleqsuvy
baclofen
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Azurity Pharm.

A new oral suspension formulation for spasticity due to multiple sclerosis and spinal cord injuries.

Hyftor
sirolimus
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Nobelpharma America

A new topical gel formulation for facial angiofibroma.

Igalmi
dexmedetomidine
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BioXcel Therapeutics

A new sublingual film formulation for acute agitation associated with schizophrenia or bipolar I or II disorder.

Kyzatrex
testosterone undecanoate
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Marius Pharmaceuticals

A capsule for testosterone replacement therapy.

Norliqva
amlodipine
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CMP Pharma

New oral solution formulation calcium channel blocker.

Radicava ORS
edaravone
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Mitsubishi Tanabe Pharma America

New oral suspension formulation for amyotrophic lateral sclerosis (also known as Lou Gehrig’s disease).

Ryaltris
olopatadine/ mometasone
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Hikma Specialty

New nasal spray formulation combining an antihistamine and corticosteroid for seasonal allergic rhinitis.

Tadliq
tadalafil
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CMP Development

New oral suspension formulation for pulmonary hypertension.

Tlando
testosterone undecanoate
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Antares

New lower-strength capsules for testosterone replacement therapy.

Tpoxx
tecovirimat
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SIGA Technologies

New formulation injectable treatment for smallpox disease.

Vijoice
alpelisib
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Novartis

New kinase inhibitor formulation for PIK3CA-Related Overgrowth Spectrum.

Xelstrym
dextroamphetamine
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Noven Therapeutics

New transdermal patch formulation for ADHD.

Zonisade
zonisamide
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Azurity Pharmaceuticals

New oral suspension for partial-onset seizures.

Zoryve
roflumilast
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Arcutis Biotherapeutics

New topical formulation for plaque psoriasis.

Brand/Generic Company Description
Ukoniq
umbralisib
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TG Therapeutics

Withdrawn due to possible increased risk of death.

Zelnorm
tegaserod
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Alfasigma

Withdrawn for business reasons, not due to safety or efficacy concerns.