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Drugs Targeting CD20 in Multiple Sclerosis: Pharmacology, Efficacy, Safety, and Tolerability Drugs (IF 11.5) Pub Date : 2024-03-14 Alise K. Carlson, Moein Amin, Jeffrey A. Cohen
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Tamoxifen Dose De-Escalation: An Effective Strategy for Reducing Adverse Effects? Drugs (IF 11.5) Pub Date : 2024-03-14
Abstract Tamoxifen, a cornerstone in the adjuvant treatment of estrogen receptor-positive breast cancer, significantly reduces breast cancer recurrence and breast cancer mortality; however, its standard adjuvant dose of 20 mg daily presents challenges due to a broad spectrum of adverse effects, contributing to high discontinuation rates. Dose reductions of tamoxifen might be an option to reduce treatment-related
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Comparative Efficacy of Drug Interventions on NAFLD Over 24 Weeks: A Traditional and Network Meta-Analysis of Randomized Controlled Trials Drugs (IF 11.5) Pub Date : 2024-03-13 Yifan Wang, He Yi, Weixia Sun, Hekai Yu, Wenxuan Tao, Xiaojin Yu, Dianrong Jia, Yingzhao Liu, Stephen J. Pandol, Ling Li
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Fidanacogene Elaparvovec: First Approval Drugs (IF 11.5) Pub Date : 2024-03-12 Sohita Dhillon
Fidanacogene elaparvovec (PrBEQVEZ™) is an adeno-associated viral (AAV) vector-based gene therapy developed by Spark Therapeutics (a subsidiary of Roche) and Pfizer (under a license from Spark Therapeutics) for the treatment of haemophilia B. In December 2023, fidanacogene elaparvovec received its first approval for the treatment of adults (aged ≥ 18 years) with moderately severe to severe haemophilia
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Opioids for Acute Musculoskeletal Pain: A Systematic Review with Meta-Analysis Drugs (IF 11.5) Pub Date : 2024-03-07 Caitlin M. P. Jones, Aili Langford, Chris G. Maher, Christina Abdel Shaheed, Richard Day, Chung-Wei Christine Lin
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SER-109 (VOWST™): A Review in the Prevention of Recurrent Clostridioides difficile Infection Drugs (IF 11.5) Pub Date : 2024-03-05 Hannah A. Blair
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Aponermin: First Approval Drugs (IF 11.5) Pub Date : 2024-03-05 Sohita Dhillon
Aponermin (沙艾特) is a recombinant circularly permuted human tumour necrosis factor-related apoptosis-inducing ligand (TRAIL) developed by Beijing Sunbio Biotech (a wholly owned subsidiary of Wuhan Hiteck Biological Pharma CO., LTD) for the treatment of multiple myeloma. Aponermin binds to and activates the death receptors 4 and/or 5 on tumour cells, triggering intracellular caspase reactions and inducing
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Adult-Onset Still’s Disease (AOSD): Advances in Understanding Pathophysiology, Genetics and Emerging Treatment Options Drugs (IF 11.5) Pub Date : 2024-03-05 Sara Bindoli, Chiara Baggio, Andrea Doria, Paolo Sfriso
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Microencapsulated Benzoyl Peroxide for Rosacea in Context: A Review of the Current Treatment Landscape Drugs (IF 11.5) Pub Date : 2024-02-29
Abstract Rosacea, a chronic skin condition affecting millions of people in the USA, leads to significant social and professional stigmatization. Effective management strategies are crucial to alleviate symptoms and improve patients’ quality of life. Encapsulated benzoyl peroxide 5% (E-BPO 5%) is a newly FDA-approved topical treatment for rosacea that shows promise in enhancing therapeutic response
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Apadamtase Alfa: First Approval Drugs (IF 11.5) Pub Date : 2024-02-29 Young-A. Heo
Apadamtase alfa (ADAMTS13, recombinant-krhn; ADZYNMA), a human recombinant form of a disintegrin and metalloproteinase with thrombospondin motifs 13 (ADAMTS13), is being developed by Takeda under license from KM biologics for thrombotic thrombocytopenic purpura (TTP) and sickle cell disease. On 9 November 2023, apadamtase alfa was approved in the USA for prophylactic and on-demand enzyme replacement
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A Neuroanatomic and Pathophysiologic Framework for Novel Pharmacological Approaches to the Treatment of Post-traumatic Stress Disorder Drugs (IF 11.5) Pub Date : 2024-02-28 Michael A. Norred, Zachary D. Zuschlag, Mark B. Hamner
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Eplontersen: First Approval Drugs (IF 11.5) Pub Date : 2024-02-28 Tina Nie
Eplontersen (Wainua™) is a ligand-conjugated antisense oligonucleotide directed to TTR, which is being developed by Ionis Pharmaceuticals and AstraZeneca for the treatment of TTR-mediated amyloidosis (ATTR). Eplontersen, which is targeted to the liver by a ligand containing three N-acetyl galactosamine residues, binds to wild-type and variant TTR mRNA, thus reducing the levels of circulating TTR protein
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Nirogacestat: First Approval Drugs (IF 11.5) Pub Date : 2024-02-27 Susan J. Keam
Nirogacestat (OGSIVEO™) is an oral, selective, reversible, small molecule γ-secretase inhibitor developed by SpringWorks Therapeutics, Inc. γ-Secretase is a multi-subunit protease complex that cleaves multiple transmembrane protein complexes, including Notch and membrane-bound B-cell maturation antigen (BCMA). Inhibition of γ-secretase may result in growth inhibition of tumour cells overexpressing
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Berdazimer Topical Gel, 10.3%: First Approval Drugs (IF 11.5) Pub Date : 2024-02-27 Susan J. Keam
Berdazimer topical gel, 10.3% (ZELSUVMI™) is a nitric oxide (NO) releasing topical gel developed by Novan Inc. (a Ligand Pharmaceuticals company) for the treatment of molluscum contagiosum (MC). Novan has used their proprietary NO-based technology platform (NITRICIL™), which stores gaseous NO species on large polymers, in the development of berdazimer topical gel, 10.3%. In January 2024, berdazimer
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Vonoprazan: A Review in Helicobacter pylori Infection Drugs (IF 11.5) Pub Date : 2024-02-23
Abstract Treatment for the eradication of Helicobacter pylori infection, a leading cause of peptic ulcer disease and an important risk factor for gastric cancer and mucosa-associated lymphoid tissue lymphoma, is indicated whenever infection is identified. However, treatment success rates with current guideline-recommended proton-pump inhibitor (PPI)-based regimens remain suboptimal, with one potential
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Etrasimod: First Approval Drugs (IF 11.5) Pub Date : 2024-02-23 Matt Shirley
Etrasimod (VELSIPITY™) is an orally available, small-molecule selective sphingosine-1-phosphate (S1P) receptor modulator being developed by Pfizer for the treatment of ulcerative colitis and other immune-mediated inflammatory disorders. Etrasimod is selective for S1P receptor subtypes S1P1, S1P4 and S1P5 while having minimal activity on S1P3 and no activity on S1P2. Etrasimod received its first approval
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Tirzepatide: A Review in Type 2 Diabetes Drugs (IF 11.5) Pub Date : 2024-02-23 Nicole L. France, Yahiya Y. Syed
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Lebrikizumab: First Approval Drugs (IF 11.5) Pub Date : 2024-02-23
Abstract Lebrikizumab (Ebglyss®) is a subcutaneous recombinant humanized IgG4 anti-IL-13 monoclonal antibody developed by Almirall S.A. and Eli Lilly and Company for the treatment of atopic dermatitis (AD). In November 2023, lebrikizumab was approved in the EU for the treatment of moderate-to-severe AD in adults and adolescents 12 years and older with a body weight of at least 40 kg who are candidates
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Capivasertib: First Approval Drugs (IF 11.5) Pub Date : 2024-02-23 Matt Shirley
Capivasertib (Truqap™) is an orally available, small-molecule pan-AKT inhibitor being developed by AstraZeneca for the treatment of various cancers, including breast and prostate cancers. Capivasertib received its first approval, in the USA, in November 2023 for use in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor 2
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Methadone for Cancer Pain Management in Children: A Review of Literature Drugs (IF 11.5) Pub Date : 2024-02-07
Abstract Pain associated with cancer is a common feature among children and adolescents. Among opioids, methadone is a unique drug for its multiple mechanisms of action. Methadone is currently underutilized in children. The use of methadone for cancer pain management in children was assessed in a systematic review. Altogether, 141 children receiving methadone were examined, and another 126 children
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Repotrectinib: First Approval Drugs (IF 11.5) Pub Date : 2024-01-27 Sohita Dhillon
Repotrectinib (AUGTYRO™) is a next-generation, oral, small-molecule kinase inhibitor of proto-oncogene tyrosine-protein kinase ROS1 (ROS1) and tropomyosin receptor tyrosine kinases (TRKs) TRKA, TRKB, and TRKC. It is being developed by Turning Point Therapeutics, a wholly owned subsidiary of Bristol-Myers Squibb (BMS), for the treatment of locally advanced or metastatic solid tumours, including non-small
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Long-Term Efficacy and Tolerability of PCSK9 Targeted Therapy: A Review of the Literature Drugs (IF 11.5) Pub Date : 2024-01-25 Willemijn A. M. Schonck, Erik S. G. Stroes, G. Kees Hovingh, Laurens F. Reeskamp
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Chinese Herbal Medicines for Coronary Heart Disease: Clinical Evidence, Pharmacological Mechanisms, and the Interaction with Gut Microbiota Drugs (IF 11.5) Pub Date : 2024-01-24 Linhai Cao, Hongxia Ni, Xiaoxiao Gong, Ziyan Zang, Hui Chang
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Lumasiran: A Review in Primary Hyperoxaluria Type 1 Drugs (IF 11.5) Pub Date : 2024-01-22 Connie Kang
Lumasiran (Oxlumo®), a first-in-class synthetic, double-stranded, ribonucleic acid (RNA) interference molecule targeting glycolate oxidase through silencing HAO1 mRNA, is approved in several countries for patients of any age and stage of kidney function with primary hyperoxaluria type 1 (PH1). Approval was based on results from the phase III ILLUMINATE trials. In the double-blind, placebo-controlled
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Remdesivir Discontinuation Decisions Based on Thresholds of Aminotransferase in an Observational Registry Drugs (IF 11.5) Pub Date : 2024-01-10 Jonathan Schimmel, Lindsey Claire Epperson, Kim Aldy, Paul Wax, Jeffrey Brent, Jennie Buchanan, Michael Levine, Keith Burkhart
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Poly-Agonist Pharmacotherapies for Metabolic Diseases: Hopes and New Challenges Drugs (IF 11.5) Pub Date : 2023-12-21 Camille Allard, Daniela Cota, Carmelo Quarta
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Spesolimab for the Treatment of Generalized Pustular Psoriasis Drugs (IF 11.5) Pub Date : 2023-12-20 Diana Bernardo, Diamant Thaçi, Tiago Torres
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Narlumosbart: First Approval Drugs (IF 11.5) Pub Date : 2023-12-19 Sohita Dhillon
Narlumosbart (津立生) is a recombinant, fully human, anti-receptor activator of nuclear factor kappa-Β ligand (RANKL) IgG4 monoclonal antibody being developed by CSPC Pharmaceutical and its wholly owned subsidiary Shanghai Jinmante Biotechnology for the treatment of giant cell tumour of bone (GCTB), bone metastases from solid tumours and osteoporosis. The RANK/RANKL signalling pathway plays a pivotal
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Reply to the Comments on “Recent Human Papillomavirus Vaccination is Associated with a Lower Risk of COVID-19: A US Database Cohort Study” Drugs (IF 11.5) Pub Date : 2023-12-18 Thomas Yen-Ting Chen, Qianru Zhang, Yao-Min Hung, Renin Chang, Shiow-Ing Wang, James Cheng-Chung Wei
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Targeting KRAS-Mutated Gastrointestinal Malignancies with Small-Molecule Inhibitors: A New Generation of Breakthrough Therapies Drugs (IF 11.5) Pub Date : 2023-12-18 Bennett A. Caughey, John H. Strickler
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Vamorolone: First Approval Drugs (IF 11.5) Pub Date : 2023-12-16 Susan J. Keam
Vamorolone (AGAMREE®) is an oral, selective, dissociative corticosteroid developed by ReveraGen BioPharma and Santhera Pharmaceuticals for the treatment of patients with muscular dystrophy. Vamorolone was approved in October 2023 for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older in the USA and received a positive opinion in the EU in October 2023 for the treatment
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Pharmacological Treatments of Temporomandibular Disorders: A Systematic Review Including a Network Meta-Analysis Drugs (IF 11.5) Pub Date : 2023-12-16
Abstract Objective Temporomandibular disorders (TMD) comprise a cluster of conditions with a wide range of etiological factors that causes pain and discomfort in the masticatory muscles (TMD-M) and temporomandibular joints (TMD-J). More than 50% of the patients with TMD report regular usage of drugs. However, there is still no consensus, nor is there any evidence-based support for clinicians when choosing
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New Therapies on the Horizon for Primary Biliary Cholangitis Drugs (IF 11.5) Pub Date : 2023-12-12 Atsushi Tanaka
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Gepirone Extended-Release: First Approval Drugs (IF 11.5) Pub Date : 2023-12-11 Susan J. Keam
Gepirone HCL extended-release (gepirone ER; EXXUA™), an oral, selective serotonin (5HT)1A receptor agonist formulated for once-daily administration, has been developed by Fabre-Kramer Pharmaceuticals, Inc. for the treatment of psychiatric disorders, including major depressive disorder (MDD). In September 2023, gepirone ER was approved in the USA for the treatment of adults with MDD. This article summarizes
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Efficacy and Safety of the Travoprost Intraocular Implant in Reducing Topical IOP-Lowering Medication Burden in Patients with Open-Angle Glaucoma or Ocular Hypertension Drugs (IF 11.5) Pub Date : 2023-12-07 John P. Berdahl, Steven R. Sarkisian, Robert E. Ang, Long V. Doan, Angela C. Kothe, Dale W. Usner, L. Jay Katz, Tomas Navratil
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Nedosiran: First Approval Drugs (IF 11.5) Pub Date : 2023-12-07 Yahiya Y. Syed
Nedosiran (RIVFLOZA™), a once-monthly subcutaneous small interfering RNA (siRNA) therapy, is being developed by Dicerna Pharmaceuticals, a Novo Nordisk company, for the treatment of primary hyperoxaluria (PH). It reduces oxalate overproduction by inhibiting the expression of the hepatic lactate dehydrogenase (LDH) enzyme. Nedosiran received its first approval on 29 September 2023 in the USA to lower
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Waldenström Macroglobulinemia: Targeted Agents Taking Center Stage Drugs (IF 11.5) Pub Date : 2023-12-06 Shayna Sarosiek, Jorge J. Castillo
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Iruplinalkib: First Approval Drugs (IF 11.5) Pub Date : 2023-11-27 Susan J. Keam
Iruplinalkib (Trade name: 启欣可®; Code name: WX-0593), a highly selective oral anaplastic lymphoma kinase (ALK) and c-ros oncogene 1 (ROS1) tyrosine kinase inhibitor (TKI), is being developed by Qilu Pharmaceutical Co., Ltd. for the treatment of ALK-positive (ALK+) or ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC). In June 2023, iruplinalkib was approved in China for the treatment of patients
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Motixafortide: First Approval Drugs (IF 11.5) Pub Date : 2023-11-23 Sheridan M. Hoy
Motixafortide (APHEXDATM) is a selective C-X-C motif chemokine receptor 4 (CXCR4) inhibitor being developed by BioLineRx under licence from Biokine Therapeutics for the mobilization of haematopoietic stem cells (HSCs) and the treatment of various cancers. On 11 September 2023, motixafortide was approved in the USA for use in combination with filgrastim [granulocyte colony stimulating factor (G-CSF)]
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Momelotinib: First Approval Drugs (IF 11.5) Pub Date : 2023-11-21 Susan J. Keam
Momelotinib (OJJAARA) is an oral Janus kinase 1 and 2 (JAK1/JAK2) and activin A receptor, type I (ACVR1) inhibitor that has been developed for the treatment of myelofibrosis (MF). In September 2023, momelotinib was approved in the USA for the treatment of intermediate or high-risk MF, including primary MF or secondary MF [post-polycythemia vera (PV) and post-essential thrombocythemia (ET)], in adults
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Mitapivat: A Review in Pyruvate Kinase Deficiency in Adults Drugs (IF 11.5) Pub Date : 2023-11-22 Amy Zhuang-Yan, Matt Shirley
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Sunvozertinib: First Approval Drugs (IF 11.5) Pub Date : 2023-11-14 Sohita Dhillon
Sunvozertinib (舒沃哲®) is an oral, irreversible, epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) being developed by Dizal Pharmaceuticals (a joint venture company formed by AstraZeneca and the Chinese Future Industry Investment Fund) for the treatment of non-small cell lung cancer (NSCLC). Sunvozertinib has potent activity against EGFR mutations, including EGFR exon 20 insertion
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Aetiology of Significant Liver Test Abnormalities in a Single-Centre Cohort of People with Cystic Fibrosis Exposed to Elexacaftor/Tezacaftor/Ivacaftor, Utilizing the Updated RUCAM Drugs (IF 11.5) Pub Date : 2023-11-15 Daniel Tewkesbury, Andrew M. Jones, Rowland Bright-Thomas, Alyn Cratchley, Karen Piper Hanley, Judith Wyatt, Varinder Athwal, Peter J. Barry
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Elranatamab: First Approval Drugs (IF 11.5) Pub Date : 2023-11-04 Sohita Dhillon
Elranatamab (elranatamab-bcmm; ELREXFIO™) is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T cell engager being developed by Pfizer for the treatment of multiple myeloma (MM). Elranatamab bridges CD3 on T cells with BCMA expressed on multiple myeloma cells, thereby activating T cells to induce T cell-mediated cytotoxicity against myeloma cells. In August 2023, elranatamab received its
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Current and Emerging Treatment Options for Uterine Fibroids Drugs (IF 11.5) Pub Date : 2023-11-03 Mohamed Ali, Michał Ciebiera, Marta Wlodarczyk, Samar Alkhrait, Elise Maajid, Qiwei Yang, Shih-Min Hsia, Ayman Al-Hendy
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Correction to: Lotilaner Ophthalmic Solution 0.25%: First Approval. Drugs (IF 11.5) Pub Date : 2023-11-01 Yahiya Y Syed
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Current and Future Treatment Landscape for Idiopathic Pulmonary Fibrosis Drugs (IF 11.5) Pub Date : 2023-10-26 Francesco Bonella, Paolo Spagnolo, Chris Ryerson
Idiopathic pulmonary fibrosis (IPF) remains a disease with poor survival. The pathogenesis is complex and encompasses multiple molecular pathways. The first-generation antifibrotics pirfenidone and nintedanib, approved more than 10 years ago, have been shown to reduce the rate of progression, increase the length of life for patients with IPF, and work for other fibrotic lung diseases. In the last two
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Zuranolone: First Approval Drugs (IF 11.5) Pub Date : 2023-10-26 Young-A Heo
Zuranolone (ZURZUVAE™) is an oral neuroactive steroid and a positive allosteric modulator of the gamma aminobutyric acid A (GABAA) receptor being developed by Sage Therapeutics and Biogen for the treatment of mood disorders. In August 2023, zuranolone received its first approval in the USA for the treatment of adults with postpartum depression [pending scheduling by the US Drug Enforcement Administration
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Pozelimab: First Approval Drugs (IF 11.5) Pub Date : 2023-10-19 Sheridan M. Hoy
Pozelimab (pozelimab-bbfg; VEOPOZ™) is a fully human immunoglobulin (Ig) G4P (i.e. IgG4 with a proline substitution to promote stabilization of the disulfide bonds between the two heavy chains) monoclonal antibody developed by Regeneron Pharmaceuticals Inc., to block the activity of complement factor 5 (C5) and prevent diseases mediated by the complement pathway. In August 2023, pozelimab received
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Lotilaner Ophthalmic Solution 0.25%: First Approval Drugs (IF 11.5) Pub Date : 2023-10-16 Yahiya Y. Syed
Lotilaner ophthalmic solution 0.25% (XDEMVY™), a gamma-aminobutyric acid-gated chloride channel (GABA-Cl) inhibitor selective for mites, is being developed by Tarsus Pharmaceuticals for the treatment of Demodex blepharitis and meibomian gland dysfunction in patients with Demodex lid infestation (Demodex-induced meibomianitis). On 24 July 2023, lotilaner ophthalmic solution 0.25% received its first
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Tafolecimab: First Approval Drugs (IF 11.5) Pub Date : 2023-10-17 Susan J. Keam
Tafolecimab (SINTBILO®), a subcutaneously administered anti-proprotein convertase subtilisin/kexin type 9 enzyme (PCSK9) monoclonal antibody, is being developed by Innovent for the treatment of hypercholesterolemia and mixed hyperlipidemia. Tafolecimab was approved in August 2023 in China as an adjunct to diet, in combination with a statin or statin with other low-density lipoprotein cholesterol (LDL-C)-lowering
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Current Medical Therapy for Adenomyosis: From Bench to Bedside Drugs (IF 11.5) Pub Date : 2023-10-14 Andrea Etrusco, Fabio Barra, Vito Chiantera, Simone Ferrero, Stefano Bogliolo, Giulio Evangelisti, Engin Oral, Mariana Pastore, Alberto Izzotti, Renato Venezia, Marcello Ceccaroni, Antonio Simone Laganà
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The Place of Cannabinoids in the Treatment of Gynecological Pain Drugs (IF 11.5) Pub Date : 2023-10-13 Justin Sinclair, Jason Abbott, Andrew Proudfoot, Mike Armour
Cannabis sativa (L), a plant with an extensive history of medicinal usage across numerous cultures, has received increased attention over recent years for its therapeutic potential for gynecological disorders such as endometriosis, chronic pelvic pain, and primary dysmenorrhea, due at least in part to shortcomings with current management options. Despite this growing interest, cannabis inhabits an
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Emerging Urate-Lowering Drugs and Pharmacologic Treatment Strategies for Gout: A Narrative Review Drugs (IF 11.5) Pub Date : 2023-10-11 Robert Terkeltaub
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Avacincaptad Pegol: First Approval Drugs (IF 11.5) Pub Date : 2023-10-09 Connie Kang
Avacincaptad pegol (IZERVAY™; formerly Zimura®) is a complement C5 inhibitor that is being developed by IVERIC Bio, an Astellas company, for the treatment of geographic atrophy secondary to age-related macular degeneration. Avacincaptad pegol recently received approval for the treatment of adults with geographic atrophy secondary to age-related macular degeneration. This article summarizes the milestones
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Talquetamab: First Approval Drugs (IF 11.5) Pub Date : 2023-10-04 Susan J. Keam
Talquetamab (talquetamab-tgvs; TALVEY®), a humanized, bispecific G-protein coupled receptor family C group 5 member D (GPRC5D)-directed CD3 T-cell engager, is being developed by Janssen for the treatment of multiple myeloma (MM). In early August 2023, talquetamab was granted accelerated approval in the USA for the treatment of adults with relapsed or refractory MM (RRMM) and in late August 2023, talquetamab
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Correction to: Birch Bark Extract: A Review in Epidermolysis Bullosa. Drugs (IF 11.5) Pub Date : 2023-10-01 Young-A Heo
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Continued Opioid Use and Adverse Events Following Provision of Opioids for Musculoskeletal Pain in the Emergency Department: A Systematic Review and Meta-Analysis Drugs (IF 11.5) Pub Date : 2023-09-28 Qiuzhe Chen, Chris G. Maher, Christopher S. Han, Christina Abdel Shaheed, Chung-Wei Christine Lin, Eileen M. Rogan, Gustavo C. Machado
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Befotertinib: First Approval Drugs (IF 11.5) Pub Date : 2023-09-26 Hannah A. Blair
Befotertinib (Surmana®) is an orally administered, highly selective, third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) being developed by Betta Pharmaceuticals and InventisBio for the treatment of non-small cell lung cancer (NSCLC). In May 2023, befotertinib was approved in China for the second-line treatment of patients with locally advanced or metastatic NSCLC
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Current Understanding of Complement Proteins as Therapeutic Targets for the Treatment of Immunoglobulin A Nephropathy Drugs (IF 11.5) Pub Date : 2023-09-25 Arun Rajasekaran, Todd J. Green, Matthew B. Renfrow, Bruce A. Julian, Jan Novak, Dana V. Rizk