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OncLive’s FDA Approval Report: The Regulatory Rundown for March 2025
03 Apr 2025 02:31 GMT
… Medical Campus, contextualized the use of tislelizumab as a frontline treatment … tumor site, grade, somatostatin receptor expression, and … 3 NIAGARA trial (NCT03732677) supported the FDA’s … and Harvard Medical School, detailed clinical trials investigating …
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Mainline Biosciences discovers new peptide-drug conjugates for cancer
02 Apr 2025 18:46 GMT
… described peptide-drug conjugates consisting of peptide targeting somatostatin receptors covalently bound … to be useful for the treatment of cancer.
BioWorld Science Cancer …
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Behind the FDA Approval: Cabozantinib for Advanced Neuroendocrine Tumors
02 Apr 2025 16:36 GMT
… Trials Network. It was a randomized, double-blinded, placebo-controlled trial … therapy targeting the somatostatin receptor, molecularly … of treatment efficacy.
References:
1. FDA approves … fda.gov/drugs/;resources-information-approved-drugs/fda …
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Crinetics Pharmaceuticals Announces European Medicines Agency (EMA) Validation of Marketing Authorization Application (MAA) and Orphan Drug Designation (ODD) for Paltusotine in Acromegaly
27 Mar 2025 20:05 GMT
… trials that evaluated paltusotine for the treatment of acromegaly in medically … Drug Administration (FDA) of the New Drug Application (NDA) for paltusotine for the treatment … Pharmaceuticals
Crinetics Pharmaceuticals is a clinical stage pharmaceutical …
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FDA approves Exelixis’ Cabometyx to treat advanced neuroendocrine tumours
31 Mar 2025 11:37 GMT
The US Food and Drug Administration (FDA) has approved Exelixis’ Cabometyx (cabozantinib) … from the late-stage CABINET trial, which evaluated Cabometyx against … important new treatment option for patients, without limitations based on somatostatin receptor …
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Dr Chan on the FDA Approval of Cabozantinib for Pancreatic and Extra-Pancreatic Neuroendocrine Tumors
28 Mar 2025 19:16 GMT
… associate professor of medicine at Harvard Medical School and clinical … the FDA approval of cabozantinib (Cabometyx) for the treatment of … the phase 3 CABINET trial (NCT03375320), which showed … well as those with somatostatin receptor–positive and –negative …
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How bioconjugation is unlocking the next generation of drug development
27 Mar 2025 20:09 GMT
… -saving treatments.
How bioconjugates transform treatment
Alongside creating new treatments for … that have advanced drug development across the pharmaceutical industry. Its … investigational medicinal product (IMP) or drug substance for first clinical trials …
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FDA Approves Cabozantinib for Advanced Neuroendocrine Tumors
26 Mar 2025 21:23 GMT
… FDA announced the approval of cabozantinib for the treatment … of Medicine.
The multicenter, double-blind phase 3 trial … according to concurrent somatostatin analogue use and … ;www.fda.gov/drugs/;resources-information-approved-drugs/fda-approves- …
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FDA Approves Cabozantinib in Pancreatic/Extra-Pancreatic Neuroendocrine Tumors
26 Mar 2025 16:21 GMT
… the phase 3 CABINET trial (NCT03375320), in which … England Journal of Medicine showed that treatment with cabozantinib … 1 prior therapy, excluding somatostatin analogs, in both … and Drug Administration (FDA) accepted the supplemental New Drug Application …
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FDA Approves Cabozantinib for Advanced Pancreatic Neuroendocrine Tumors
26 Mar 2025 19:12 GMT
… Cabometyx; Exelixis) received FDA approval after demonstrating a … tumors (epNET).1 The drug is indicated to treat … trial results were presented at the 2024 European Society for Medical … treatment option for patients, without limitations based on somatostatin …