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Pharma Sapience New Drug Approval 61859858 2025 06-07-11 52

The document lists various drugs approved by the USFDA from June 2024 onwards, detailing their active ingredients and FDA-approved uses. Notable approvals include treatments for conditions such as dry eye disease, non-small cell lung cancer, and hemophilia. The list encompasses a wide range of therapeutic areas, highlighting advancements in medical treatments.

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0% found this document useful (0 votes)
5 views3 pages

Pharma Sapience New Drug Approval 61859858 2025 06-07-11 52

The document lists various drugs approved by the USFDA from June 2024 onwards, detailing their active ingredients and FDA-approved uses. Notable approvals include treatments for conditions such as dry eye disease, non-small cell lung cancer, and hemophilia. The list encompasses a wide range of therapeutic areas, highlighting advancements in medical treatments.

Uploaded by

bpambalwar
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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🧬USFDA Drug Approvals (June 2024 Onwards)🧬

Drug Name Active Ingredient FDA-approved use


Tryptyr acoltremon Dry eye disease
Emrelis telisotuzumab non-squamous non-small cell lung
vedotin-tllv cancer (NSCLC)
Avmapki Fakzynja avutometinib and KRAS-mutated recurrent low-grade
Co-Pack defactinib serous ovarian cancer (LGSOC)
Imaavy nipocalimab-aahu Generalized myasthenia gravis
penpulimab-kcqx penpulimab-kcqx Non-keratinizing nasopharyngeal
carcinoma (NPC)
Vanrafia atrasentan To reduce proteinuria in adults with
primary immunoglobulin
Qfitlia fitusiran Prevent or reduce the frequency of
bleeding episodes in hemophilia A or
B
Blujepa gepotidacin Uncomplicated urinary tract
infections
Romvimza vimseltinib Symptomatic tenosynovial giant cell
tumor

Gomekli mirdametinib Neurofibromatosis type 1


Journavx suzetrigine Moderate to severe acute pain
Grafapex treosulfan Preparative regimen for allogeneic
hematopoietic stem cell
transplantation for acute myeloid
leukemia and myelodysplastic
syndrome
Datroway datopotamab HR-positive, HER2-negative breast
deruxtecan-dlnk cancer
Alhemo concizumab-mtci Prophylaxis to prevent bleeding
episodes in hemophilia A and B
Alyftrek vanzacaftor, Cystic fibrosis
tezacaftor, and
deutivacaftor
Tryngolza olezarsen Familial chylomicronemia syndrome
Ensacove ensartinib Non-small cell lung cancer
Crenessity crinecerfont Classic congenital adrenal
hyperplasia
Unloxcyt cosibelimab-ipdl Cutaneous squamous cell carcinoma

Bizengri zenocutuzumab-zbco Non-small cell lung cancer and


pancreatic adenocarcinoma
Iomervu iomeprol For use as a radiographic contrast
agent
Rapiblyk landiolol Supraventricular tachycardia
Attruby acoramidis Cardiomyopathy of wild-type or
variant transthyretin-mediated
amyloidosis
Ziihera zanidatamab-hrii Unresectable or metastatic HER2-
positive (IHC 3+) biliary tract cancer
Revuforj revumenib Relapsed or refractory acute
leukemia
Orlynvah sulopenem etzadroxil, Uncomplicated urinary tract
probenecid infections (uUTI)
Vyloy zolbetuximab-clzb Gastric or gastroesophageal junction
adenocarcinoma
Hympavzi marstacimab-hncq Prevent or reduce bleeding episodes
related to hemophilia A or B
Itovebi inavolisib Locally advanced or metastatic
breast cancer
Flyrcado flurpiridaz F 18 Radioactive diagnostic drug for
myocardial ischemia and infarction
Cobenfy xanomeline and Schizophrenia
trospium chloride
Aqneursa levacetylleucine Niemann-Pick disease type C

Miply^a arimoclomol Niemann-Pick disease type C

Ebglyss lebrikizumab-lbkz Moderate-to-severe atopic dermatitis

Lazcluze lazertinib Non-small cell lung cancer

Niktimvo axatilimab-csfr Chronic graft-versus-host disease


(cGVHD)
Livdelzi seladelpar Primary biliary cholangitis (PBC)

Nemluvio nemolizumab-ilto Prurigo nodularis


Yorvipath palopegteriparatide Hypoparathyroidism

Voranigo vorasidenib Grade 2 astrocytoma or


oligodendroglioma
Leqselvi deuruxolitinib Severe alopecia areata
Kisunla donanemab-azbt Alzheimer’s disease
Ohtuvayre ensifentrine Chronic obstructive pulmonary
disease
Piasky crovalimab-akkz Paroxysmal nocturnal
hemoglobinuria
Sofdra sofpironium Primary axillary hyperhidrosis

Iqirvo elafibranor Primary biliary cholangitis


ursodeoxycholic acid
Rytelo imetelstat Low- to intermediate-1 risk
myelodysplastic syndromes

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