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<![CDATA[Correlation Observed Between Leukemia Stem Cells and Response in CML]]>
04 Nov 2025 15:26 GMT
… in patients with chronic myeloid leukemia (CML). The findings suggest the … began treatment with imatinib (Gleevec), 30% (n = 72) with nilotinib (Tasigna), and … chronic myeloid leukemia patients: Final results of prospective FLOWERS study. Cancer. 2025 …
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<![CDATA[October 2025: A Look at FDA Oncology Approvals and Designations]]>
02 Nov 2025 20:03 GMT
… SIDNEY trial (NCT04669171).
On October 21, the FDA accepted the new drug … the TKI nilotinib (Tasigna), for treatment of chronic myeloid leukemia. A PDUFA target … drug designation by the FDA for the treatment of pancreatic cancer.
The FDA granted orphan drug …
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<![CDATA[FDA Accepts NDA for New Nilotinib Formulation in Chronic Myeloid Leukemia]]>
22 Oct 2025 21:45 GMT
The US FDA has accepted the new drug application (NDA) … TKI) nilotinib (Tasigna), for treatment of chronic myeloid leukemia (CML).1 … With XS003’s NDA acceptance, a Prescription Drug … before administration, pending FDA review of final labeling …
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<![CDATA[FDA Accepts NDA for Nilotinib Biosimilar XS003 for Chronic Myeloid Leukemia]]>
21 Oct 2025 21:28 GMT
… (Tasigna), for the treatment of patients with chronic myeloid leukemia … center, randomized phase 1 trial (NCT07138352) designed to … who had an acceptable medical history, physical exam, … /tasigna.pdf
Azurity Pharmaceuticals, Inc. announces FDA approval of …
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Novartis' new drugs outweigh Entresto decline in Q3
28 Oct 2025 14:05 GMT
… (secukinumab), plus generic erosion to cancer drug Tasigna (nilotinib) and Promacta/Revolade … .
Narasimhan also highlighted the recent FDA approval of Rhapsido (remibrutinib) in … assets with pipeline-in-a-pill potential that could underpin our …
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Novartis Q3: new drugs step up as generics squeeze Entresto
28 Oct 2025 15:39 GMT
… medication reduced by 1% in Q3. The drug … platelet disorder treatment Promacta (eltrombopag) and blood cancer drug Tasigna (nilotinib … Avidity Biosciences, a biotech developing RNA therapeutics. … you deserve! The Pharmaceutical Technology Excellence Awards …
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<![CDATA[FDA Accepts NDA for New Nilotinib Formulation in CML]]>
24 Oct 2025 02:15 GMT
… a treatment for patients with chronic myeloid leukemia … FDA accepts new drug application for XS003 (nilotinib) for the treatment … 45zjp4xs
Tasigna® (nilotinib) Capsules. Prescribing information. FDA. … News release. Azurity Pharmaceuticals, Inc. November 14 …
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2024 First Generic Drug Approvals
23 Oct 2025 18:33 GMT
… lymphoma; multiple myeloma, leukemias, mycosis fungoides, neuroblastoma … 2024
Metastatic breast cancer, after failure of … treatment of erectile dysfunction
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215570
Palbociclib Tablets
Synthon Pharmaceuticals … 18 mg
Indoco Remedies Limited
Lucemyra (Lofexidine …
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<![CDATA[Emerging Use of an Allosteric TKI: Asciminib for the Treatment of Chronic Myeloid Leukemia]]>
18 Oct 2025 00:57 GMT
… nilotinib (Tasigna; Novartis), and ponatinib (Iclusig; Takeda Pharmaceutical Company). … trials (ACTRN12620000851965).4,13,14
The ASC4FIRST trial … the National Comprehensive Cancer Network now offer … frontline treatment of chronic-phase chronic myeloid leukemia: …
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FDA throws cold water on Xspray's latest approval bid with rejection over manufacturing, label concerns
09 Oct 2025 23:15 GMT
… in chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL) with … implemented a remediation plan and will meet with the FDA later … funds to take the drug to the FDA finish line.
However, … 39; Tasigna that's expected to undergo an FDA review, …