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August 5, 2022 Posting | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
19 Dec 2025 19:11 GMT
… labeling
PD-1 Blocking Antibody (Drug class)
Bavencio (avelumab)
Imfinzi … (nivolumab)
Tecentriq
(atezolizumab)
Tuberculosis
FDA decided that no action is … necrolysis (TEN).
Tecentriq labeling
Xalkori (crizotinib)
Blood creatine phosphokinase …
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<![CDATA[FDA Accepts NDA for Zidesamtinib in Advanced ROS1+ NSCLC]]>
20 Nov 2025 23:45 GMT
… Drilon, ARROS-1 trial investigator, added.3 … repotrectinib (Augtyro), crizotinib (Xalkori), entrectinib (Rozlytrek), and taletrectinib … 2024 European Society for Medical Oncology (ESMO) … FDA acceptance of new drug application for zidesamtinib for the treatment …
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<![CDATA[Your Genes, Your Treatment: Biomarker Testing and Lung Cancer ]]>
20 Nov 2025 23:11 GMT
… into an individually tailored treatment approach.
“Biomarker … University School of Medicine, and associate cancer … Ensacove (ensartinib)
ROS1 rearrangements: Xalkori, Zykadia, Rozlytrek (entrectinib), … shared how antibody-drug conjugates have become …
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<![CDATA[FDA Accepts NDA for Zidesamtinib in Pretreated Advanced ROS1+ NSCLC]]>
20 Nov 2025 20:32 GMT
… 1. Results from the trial were shared in the … ROS1 TKI of either crizotinib (Xalkori) or entrectinib (Rozlytrek), … of Early Drug Development Service and a thoracic medical oncologist … FDA acceptance of new drug application for zidesamtinib for the treatment …
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Anticancer Drugs Market Set to Expand at 9.14% CAGR, Reaching USD 401.32 Billion by 2034
21 Nov 2025 13:00 GMT
… drugs, making treatment more accessible. Focus on personalised medicine: … and emerging economies. Pharmaceutical companies are also … Squibb. Clinical Trials & Approval Clinical trials start with … , Pfizer received FDA approval for Xalkori XR, an extended …
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<![CDATA[FDA Clears Oncomine Dx Target Test as Companion Diagnostic for Sevabertinib in NSCLC]]>
21 Nov 2025 00:11 GMT
… received prior treatment, including HER2-targeted antibody-drug conjugates ( … ;2 SOHO-01 trial showed strong responses, … ), selpercatinib (Retevmo), crizotinib (Xalkori)
Cholangiocarcinoma: Ivosidenib (Tibsovo)
… Division of Internal Medicine at The University …
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Trump to sign executive order to reduce cost of prescription drugs and pharmaceuticals up to 80%
12 May 2025 02:18 GMT
… wrote.
'The Pharmaceutical/Drug Companies would say, … Xeljanz, a treatment for autoimmune diseases including … Xalkori.
Drugmakers hiked up the prices of more than 770 drugs in 2024 alone — including medications … seen by a doctor. With insurance, copays …
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FDA Backs Darovasertib Phase 3 Trial Design in Uveal Melanoma
14 Apr 2025 23:38 GMT
… trial," said Darrin Beaupre, MD, PhD, chief medical … its combination with crizotinib (Xalkori) in metastatic uveal … IDEAYA Biosciences receives US FDA breakthrough therapy designation … drug designation for darovasertib, a PKC inhibitor, for the treatment …
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Immunotherapy and T-Cell–Directed Therapy Expand Treatment Approaches in Small Cell Lung Cancer
14 Aug 2025 18:48 GMT
… as the Clinical Research Medical Director at the … personalized treatments, novel targets, and innovative approaches. Antibody-drug … 3 CROWN (NCT03052608) trials advanced the understanding of … inhibitor, with crizotinib [Xalkori], an earlier-generation ALK …
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Pledging ‘Radical Transparency,’ FDA Reveals Drug Rejection Letters — With Limits
13 Jul 2025 18:50 GMT
… established ROS1 inhibitors Xalkori from Pfizer and … vaccine as mNEXSPIKE. In the key clinical trial … FDA approved KalVista Pharmaceuticals’ Ekterly, making the pill the first oral on-demand treatment … a drug that the biotech had developed as a treatment for …