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Vamorolone

New Drug Approvals

The synthesis is disclosed in Bioorganic & Medicinal Chemistry, Volume 21 , Issue 8, 15 April 2013, Pages 2241-2249. Hoffman, Efficacy and safety of vamorolone vs placebo and prednisone among boys with duchenne muscular dystrophy: a randomized clinical trial, JAMA Neurol. 21 (2013) 2241–2249. 2013, 21, 2241− 2249.

FDA
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Elacestrant 

New Drug Approvals

2] Elacestrant was approved for medical use in the United States in January 2023, [1] [2] [5] [6] and in the European Union in September 2023. [3] 2] The FDA granted the application for elacestrant priority review and fast track designations. [2] Food and Drug Administration (FDA). 1] [4] It is taken by mouth. [1] PMC 9340905.

FDA
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PRITELIVIR MESYLATE

New Drug Approvals

Clinical Trials: Pritelivir is currently in phase II clinical trials, with ongoing research into its effectiveness and safety. Clinical Trials: Pritelivir mesylate is currently under extensive study to evaluate its efficacy and safety profile, with promising results in early clinical trials. References ^ Wilck, M.B.;

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Levers for Biological Progress

Codon

Although Amodei does acknowledge some real-world issues limiting scientific progress — such as the slow growth of organisms and tedious clinical trials — he mostly passes over the more general tools that will be required to accelerate research in the near term. This essay focuses on how we might do both, specifically for the cell.

DNA
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Importance of Patient-Reported Outcomes in Clinical Trials

Vial

PROs in clinical trials are important as they capture the patient’s perspective and ensure that the impact of an intervention is comprehensively evaluated. Food and Drug Administration (FDA) increasingly look to patients to understand how they describe their health status. What are PROs in clinical trials?

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Q&A: The IND Journey Phase I – Navigating Success

Advarra

The sponsor is the pharmaceutical company conducting the trial. If you mean using a different contract research organization (CRO) for the different phases of clinical trials – that’s different. Also consider CRO oversight, trial management, data handling and record keeping, as well as allocation of responsibilities.

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Novartis data at ACTRIMS-ECTRIMS highlight the strength of leading multiple sclerosis (MS) portfolio with life-changing therapies for people across the MS spectrum

The Pharma Data

Novartis will present 48 abstracts from its leading MS portfolio, including new data on recently FDA-approved Kesimpta ® (ofatumumab) — the first and only self-administered, targeted B-cell therapy for relapsing forms of MS (RMS )— Mayzent ® (siponimod) and Gilenya ® (fingolimod) .