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<![CDATA[FDA Oncology Update January 2026: New Horizons in Precision Medicine]]>
02 Feb 2026 20:18 GMT
… and difficult-to-treat malignancies. From pioneering … accelerating its clinical development for treatment of adult patients … ’s potential in treating an aggressive subset … treatment of patients with gastrointestinal stromal tumors (GIST).
On January 27, the FDA …
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Biodexa Announces Exclusive License of Otsuka’s OPB-171775, a potent Phase 1 ready Molecular Glue for GIST
04 Feb 2026 13:30 GMT
… to be developed for the treatment of … the management of gastrointestinal stromal tumors. Nature Clinical Practice …
Future Market Insights. Gastrointestinal Stromal Tumor (GIST) Therapeutics Market … About Biodexa Pharmaceuticals PLC Biodexa Pharmaceuticals PLC …
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<![CDATA[FDA Grants BTD to Bezuclastinib Combo in Gastrointestinal Stromal Tumors]]>
27 Jan 2026 23:13 GMT
… the treatment of patients with gastrointestinal stromal tumors ( … treatment options for nearly 2 decades.
Recently, the FDA accepted a new drug …
The developer reported … trial of CGT9486+sunitinib vs. sunitinib in subjects with gastrointestinal stromal tumors …
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Cogent Biosciences Announces Breakthrough Therapy Designation for Bezuclastinib in Combination with Sunitinib for Patients with Gastrointestinal Stromal Tumors (GIST)
26 Jan 2026 13:00 GMT
… company focused on developing precision therapies for genetically … S. Food and Drug Administration (FDA) has granted Breakthrough … with Gastrointestinal Stromal Tumors (GIST) who have received prior treatment with … from the PEAK trial which demonstrated a …
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<![CDATA[FDA Accepts NDA for Bezuclastinib Combo in Gastrointestinal Stromal Tumors]]>
21 Jan 2026 22:51 GMT
… drug application (NDA) for bezuclastinib plus sunitinib (Sutent) as treatment … for patients with gastrointestinal stromal tumors who have … the developer, Cogent Biosciences.1 The FDA’ … phase 3 trial in gastrointestinal stromal tumors (GIST). News …
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Shorla Oncology® Announces U.S. FDA Approval of Larger Vial Size for Nelarabine Intravenous Administration for the Treatment of T-cell Acute Lymphoblastic Leukemia and T-cell Lymphoblastic Lymphoma
28 Jan 2026 15:33 GMT
… of innovative oncology drugs for orphan and … for the treatment of Chronic Myeloid Leukemia, Gastrointestinal Stromal Tumors (GISTs), … FDA at 1-800-FDA-1088 orwww.fda.gov/medwatch.
DRUG … AMERICA
INDUSTRY KEYWORD: FDA PHARMACEUTICAL HEALTH ONCOLOGY
SOURCE: …
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<![CDATA[FDA Grants Designation to Bezuclastinib Combo in Advanced GIST]]>
28 Jan 2026 03:26 GMT
… S. Food and Drug Administration (FDA) has granted breakthrough … sunitinib) for patients with gastrointestinal stromal tumors (GIST) whose disease has … with the FDA and can speed the development and … used treatment after Gleevec progression.
In the PEAK trial, …
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<![CDATA[FDA Grants Breakthrough Designation for Bezuclastinib in GIST]]>
27 Jan 2026 19:25 GMT
… Sutent) for the treatment of patients with gastrointestinal stromal tumors (GIST), according … Evidence from the PEAK Trial
The FDA's decision … expedite the development and review of drugs for serious … to complete its new drug application submission for …
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Cogent's New Stomach Cancer Treatment Cuts Progression Risk In Half, Gets Breakthrough Therapy Tag
26 Jan 2026 15:37 GMT
… the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation … with Gastrointestinal Stromal Tumors (GIST).
The trial included patients who received prior treatment with … combo regimen New Drug Application (NDA) under the FDA’s Real- …
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Hoth Therapeutics Early Cancer Trial Succeeds With 100% Patient Response, Cuts Disease Severity By Half
22 Jan 2026 18:02 GMT
… -label pharmacokinetic (PK) cohort of its ongoing CLEER-001 trial evaluating … a broad and consistent treatment effect across multiple clinically relevant … gastrointestinal stromal tumors (GIST) and systemic mastocytosis as early as 24 hours post-treatment …