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Management: Food and Drug Administration (FDA)
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Total 7133 results found since Jan 2013.
Identification and structural characterization of major stress degradation products of halcinonide by liquid chromatography-high-resolution mass spectrometry
Biomed Chromatogr. 2023 Aug 31:e5730. doi: 10.1002/bmc.5730. Online ahead of print.ABSTRACTHalcinonide is a topical corticosteroid approved by the US Food and Drug Administration (FDA), known for its anti-inflammatory and antipruritic properties. The therapeutic benefits of halcinonide have rendered it an effective treatment regimen for various dermatological conditions such as psoriasis, dermatitis, and eczema. However, stability of the drug substance is a prerequisite in determining the therapeutic efficacy and plays a crucial role during formulation development and long-term storage. As corticosteroids are highly suscep...
Source: Biomedical Chromatography : BMC - August 31, 2023 Category: Biomedical Science Authors: Shivraj Giri Devendra Badgujar Sree Teja Paritala Nitish Sharma Source Type: research
Efficacy and safety of melflufen plus daratumumab and dexamethasone in relapsed/refractory multiple myeloma: results from the randomized, open-label, phase III LIGHTHOUSE study
Haematologica. 2023 Aug 31. doi: 10.3324/haematol.2023.283509. Online ahead of print.ABSTRACTMelphalan flufenamide (melflufen), a first-in-class alkylating peptide-drug conjugate, plus dexamethasone was approved in Europe for use in patients with triple-class refractory relapsed/refractory multiple myeloma (RRMM) with ≥3 prior lines of therapy and without prior autologous stem cell transplantation (ASCT) or with a time to progression >36 months after prior ASCT. The randomized LIGHTHOUSE study (NCT04649060) assessed melflufen plus daratumumab and dexamethasone (melflufen group) versus daratumumab in patients with RRMM...
Source: Haematologica - August 30, 2023 Category: Hematology Authors: Lud ěk Pour Monika Szarejko Jelena Bila Fredrik H Schjesvold Ivan Spicka Vladimir Maisnar Artur Jurczyszyn Zhanet Grudeva-Popova Roman H ájek Ganna Usenko Marcus Thuresson Stefan Norin Sara Jarefors Nicolaas A Bakker Paul G Richardson Maria-Victoria Mat Source Type: research
Recombinant Antibody Fragments for Neurological Disorders: An Update
Curr Neuropharmacol. 2023 Aug 30. doi: 10.2174/1570159X21666230830142554. Online ahead of print.ABSTRACTRecombinant antibody fragments are promising alternatives to full-length immunoglobulins, creating big opportunities for the pharmaceutical industry. Nowadays, antibody fragments such as antigen-binding fragments (Fab), single-chain fragment variable (scFv), single-domain antibodies (sdAbs), and bispecific antibodies (bsAbs) are being evaluated as diagnostics or therapeutics in pre-clinical models and in clinical trials. Immunotherapy approaches, including passive transfer of protective antibodies, have shown therapeutic...
Source: Current Neuropharmacology - August 30, 2023 Category: Drugs & Pharmacology Authors: Karen Manoutcharian Goar Gevorkian Source Type: research
A New Hope in Alzheimer's Disease Psychosis: Pimavanserin
Curr Alzheimer Res. 2023 Aug 25. doi: 10.2174/1567205020666230825124922. Online ahead of print.ABSTRACTAlzheimer's disease (AD) ranks first among the causes of dementia worldwide. AD can develop a psychotic manifest at a significant rate. AD prognosis worsens by added psychosis clinic. There is no treatment approved by the United States Food and Drug Administration (FDA) among antipsychotics for Alzheimer's disease Psychosis (ADP). However, pimavanserine, an atypical antipsychotic, has been approved by the FDA for Parkinson's psychosis. It is predicted that pimavanserin, a new antipsychotic, will fill an important gap in t...
Source: Current Alzheimer Research - August 29, 2023 Category: Neurology Authors: Faruk Kurhan Mustafa Ak ın Source Type: research
