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Total 208 results found since Jan 2013.
FDA Approval Summary: Dabrafenib in combination with trametinib for BRAF V600E mutation-positive low-grade glioma
Clin Cancer Res. 2023 Aug 23:CCR-23-1503. doi: 10.1158/1078-0432.CCR-23-1503. Online ahead of print.ABSTRACTOn March 16, 2023, the U.S. Food and Drug Administration (FDA) approved dabrafenib in combination with trametinib (Tafinlar®, Mekinist®, Novartis Pharmaceuticals Corporation) for the treatment of pediatric patients with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy. FDA also approved oral formulations of both drugs suitable for patients who cannot swallow pills. This approval was based on the LGG cohort from Study CDRB436G2201 (NCT02684058), a multicenter, open-label trial in which ...
Source: Clinical Cancer Research - August 23, 2023 Category: Cancer & Oncology Authors: Michael I Barbato Jeannette Nashed Diana Bradford Yi Ren Sachia Khasar Claudia P Miller Banu S Zolnik Hong Zhao Yangbing Li Youwei Bi Stacy S Shord Anup K Amatya Pallavi S Mishra-Kalyani Barbara Scepura Raniya A Al-Matari Richard Pazdur Paul G Kluetz Mart Source Type: research
FDA Approval Summary: Selpercatinib for the treatment of advanced RET fusion-positive solid tumors
Clin Cancer Res. 2023 May 23:CCR-23-0459. doi: 10.1158/1078-0432.CCR-23-0459. Online ahead of print.ABSTRACTOn September 21, 2022, the U.S. Food and Drug Administration (FDA) granted accelerated approval to selpercatinib (Retevmo®, Eli Lilly and Company) for the treatment of adult patients with locally advanced or metastatic solid tumors with a rearranged during transfection (RET) gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options. The approval was based on data from Study LOXO-RET-17001 (LIBRETTO-001; NCT03157128), an international, non-rand...
Source: Clinical Cancer Research - May 23, 2023 Category: Cancer & Oncology Authors: Elizabeth S Duke Diana Bradford Michelle Marcovitz Anup K Amatya Pallavi S Mishra-Kalyani Emily Nguyen Lauren S L Price Jeanne Fourie Zirkelbach Yangbing Li Youwei Bi Jeffrey Kraft Sarah E Dorff Barbara Scepura Maritsa Stephenson Idara Ojofeitimi Abhilash Source Type: research
Clinical Potential of Adrenomedullin Signaling in the Cardiovascular System
Circ Res. 2023 Apr 28;132(9):1185-1202. doi: 10.1161/CIRCRESAHA.123.321673. Epub 2023 Apr 27.ABSTRACTNumerous clinical studies have revealed the utility of circulating AM (adrenomedullin) or MR-proAM (mid-regional proAM 45-92) as an effective prognostic and diagnostic biomarker for a variety of cardiovascular-related pathophysiologies. Thus, there is strong supporting evidence encouraging the exploration of the AM-CLR (calcitonin receptor-like receptor) signaling pathway as a therapeutic target. This is further bolstered because several drugs targeting the shared CGRP (calcitonin gene-related peptide)-CLR pathway are alrea...
Source: Circulation Research - April 27, 2023 Category: Cardiology Authors: L ászló Bálint Nathan P Nelson-Maney Yanna Tian Stephen D Serafin Kathleen M Caron Source Type: research
TREMFYA ® (guselkumab) Real-World Data Analyses Show Greater Treatment Persistence Than IL-17s in Both Bio-naïve and Bio-experienced Patients Living With Moderate to Severe Plaque Psoriasis
SPRING HOUSE, PENNSYLVANIA, March 17, 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new data, showing that initiation of TREMFYA® (guselkumab) was associated with greater treatment persistencea compared to secukinumab or ixekizumab in bio-naïve and bio-experienced patientsb living with moderate to severe plaque psoriasis (PsO), based on pairwise analysesc of real-world data.[1],[2] Additionally, in a post-hoc analysis of Phase 3 VOYAGE 2 clinical trial results, TREMFYA demonstrated durable clinical efficacy, itch relief and quality-of-life improvements in patients living with scal...
Source: Johnson and Johnson - March 17, 2023 Category: Pharmaceuticals Tags: Latest News Source Type: news
Tebentafusp: a novel drug for the treatment of metastatic uveal melanoma
Drugs Today (Barc). 2023 Mar;59(3):179-193. doi: 10.1358/dot.2023.59.3.3542417.ABSTRACTOn January 25, 2022, the U.S. Food and Drug Administration (FDA) approved the use of tebentafusp, a bispecific glycoprotein 100 (gp100) peptide-human leukocyte antigen (HLA)-directed CD3 T-cell activator, for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma (mUM). Pharmacodynamic data indicate that tebentafusp targets a specific HLA-A*02:01/gp100 complex, activating both CD4+/CD8+ effector and memory T cells that induce tumor cell death. Tebentafusp is administered to patients via intrav...
Source: Cancer Control - February 27, 2023 Category: Cancer & Oncology Authors: Zhijian Wang Yuhao Xie Jing-Quan Wang Yuanhui Cheng Joshua Fleishman Zhe-Sheng Chen Yun Chen Source Type: research
Demographic and Clinical Characteristics of Mpox in Persons Who Had Previously Received 1 Dose of JYNNEOS Vaccine and in Unvaccinated Persons - 29 U.S. Jurisdictions, May 22-September 3, 2022
This report describes demographic and clinical characteristics of cases occurring ≥14 days after receipt of 1 dose of JYNNEOS vaccine and compares them with characteristics of cases among unvaccinated persons with mpox and with the vaccine-eligible vaccinated population in participating jurisdictions. During May 22-September 3, 2022, among 14,504 mpox cases reported from 29 participating U.S. jurisdictions,§ 6,605 (45.5%) had available vaccination information and were included in the analysis. Among included cases, 276 (4.2%) were among persons who had received 1 dose of vaccine ≥14 days before illness onset. Mpox cas...
Source: MMWR Morb Mortal Wkl... - December 29, 2022 Category: Epidemiology Authors: Jennifer L Farrar Nathaniel M Lewis Kennedy Houck Michelle Canning Amy Fothergill Amanda B Payne Adam L Cohen Joshua Vance Bridget Brassil Erin Youngkin Bailey Glenn Anil Mangla Nikki Kupferman Katharine Saunders Cristina Meza Dawn Nims Susan Soliva Brand Source Type: research
