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Total 276 results found since Jan 2013.
Bach1 inhibitor HPP-D mediates γ-globin gene activation in sickle erythroid progenitors
Blood Cells Mol Dis. 2023 Aug 17;104:102792. doi: 10.1016/j.bcmd.2023.102792. Online ahead of print.ABSTRACTSickle cell disease (SCD) is the most common β-hemoglobinopathy caused by various mutations in the adult β-globin gene resulting in sickle hemoglobin production, chronic hemolytic anemia, pain, and progressive organ damage. The best therapeutic strategies to manage the clinical symptoms of SCD is the induction of fetal hemoglobin (HbF) using chemical agents. At present, among the Food and Drug Administration-approved drugs to treat SCD, hydroxyurea is the only one proven to induce HbF protein synthesis, however, it...
Source: Blood Cells, Molecules and Diseases - August 26, 2023 Category: Hematology Authors: Chithra D Palani Xingguo Zhu Manickam Alagar Otis C Attucks Betty S Pace Source Type: research
FDA Approval Summary: Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma
This article summarizes key aspects of the regulatory review, including the indication statement, efficacy and safety considerations, and postmarketing requirements.PMID:37624619 | DOI:10.1158/1078-0432.CCR-23-1272
Source: Clinical Cancer Research - August 25, 2023 Category: Cancer & Oncology Authors: Deepti Telaraja Yvette L Kasamon Justin S Collazo Ruby Leong Kun Wang Ping Li Elyes Dahmane Yuching Yang Justin Earp Manuela Grimstein Lisa R Rodriguez Marc R Theoret Nicole J Gormley Source Type: research
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
Use of real-world evidence in neuroscience-related new drug and biologics license applications for novel therapeutics
Clin Pharmacol Ther. 2023 Aug 7. doi: 10.1002/cpt.3018. Online ahead of print.ABSTRACTThe US Food and Drug Administration (FDA) is evaluating the potential use of real-world evidence (RWE) in regulatory decision-making. Some groups have evaluated the use of RWE in regulatory submissions in the United States and abroad, reporting that reliance on RWE to support new product approvals is relatively common. Confusion regarding the use of RWE in drug-approval decisions may arise, however, based on different application of the terms real-world data (RWD) and RWE. We evaluated RWE in NDAs and BLAs from January 2019 to June 2021 f...
Source: Clinical Pharmacology and Therapeutics - August 7, 2023 Category: Drugs & Pharmacology Authors: Bartholt Bloomfield-Clagett Motiur Rahman Kimberly Smith John Concato Source Type: research
FDA Approval Summary: Futibatinib for Unresectable Advanced or Metastatic, Chemotherapy Refractory Intrahepatic Cholangiocarcinoma with FGFR2 Fusions or Other Rearrangements
This article summarizes the FDA's thought process and data supporting the approval of futibatinib.PMID:37289037 | DOI:10.1158/1078-0432.CCR-23-1042
Source: Clinical Cancer Research - June 8, 2023 Category: Cancer & Oncology Authors: Shruti U Gandhy Sandra J Casak Sirisha L Mushti Joyce Cheng Sriram Subramaniam Hong Zhao Miao Zhao Youwei Bi Guansheng Liu Jianghong Fan Oluseyi Adeniyi Rosane Charlab Dubravka Kufrin Matthew D Thompson Kristin Jarrell Doris Auth Steven J Lemery Richard P Source Type: research
Psychedelics: Threshold of a Therapeutic Revolution
Neuropharmacology. 2023 May 27:109610. doi: 10.1016/j.neuropharm.2023.109610. Online ahead of print.ABSTRACTThis Special Issue of Neuropharmacology on psychedelics provides a timely and comprehensive update on progress following the previous Neuropharmacology Special Issue "Psychedelics: New Doors, Altered Perceptions". Remarkable advances have been made in basic and clinical research on psychedelics in the five years since 2018. It is partly based on the seminar series focused on psilocybin organized by the National Institutes of Health (NIH), USA from April to June 2021, the "NIH Psilocybin Research Speaker Series". Part...
Source: Neuropharmacology - May 29, 2023 Category: Drugs & Pharmacology Authors: D J Heal S L Smith S J Belouin J E Henningfield Source Type: research
