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Pirtobrutinib

New Drug Approvals

7] Pirtobrutinib was approved for medical use in the United States in January 2023, [4] [8] [9] [10] and in the European Union in November 2023. [2] 7] Pirtobrutinib was approved for medical use in the United States in January 2023, [4] [8] [9] [10] and in the European Union in November 2023. [2] Food and Drug Administration (FDA).

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Leniolisib

New Drug Approvals

5] Leniolisib was approved for medical use in the United States in March 2023. [5] 5] [7] [8] It is the first approved medication for the treatment of activated PI3K delta syndrome. [5] 5] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. [9] World Health Organization (2017).

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Impulse Dynamics Announces FDA Approval for Magnetic Resonance Imaging

The Pharma Data

Biederman, Director of Cardiovascular Imaging and Cardiac MRI at Allegheny General Hospital/Allegheny Health System in Pittsburgh and an author on the groundbreaking 2017 MagnaSafe trial published in NEJM. Typically, MRI is preferred by imaging specialists because it’s the safest alternative for most patients.

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The Role of the FDA’s Oncology Center of Excellence in Advancing Cancer Care

The Premier Consulting Blog

The FDAs Oncology Center of Excellence (OCE) plays a pivotal role in fostering innovation, collaboration, and efficiency in the development and evaluation of oncology products. Provides the Oncology Dosing Toolkit. first or second line setting), considering clinical, scientific, regulatory, and operational factors.

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Gepirone

New Drug Approvals

The FDA rejected approval for gepirone in 2002 and 2004. [5] 5] It was submitted for the preregistration (NDA) phase again in May 2007 after adding additional information from clinical trials as the FDA required in 2009. 12] However, in March 2016, the FDA reversed its decision and gave gepirone ER a positive review. [13]

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Roche announces FDA approval of FoundationOne Liquid CDx, a comprehensive pan-tumour liquid biopsy test

The Pharma Data

The test is FDA-approved to report short variants in 311 genes including rearrangements and copy number losses in BRCA1 and BRCA2 genes. The results are delivered in an integrated report that identifies alterations matched to FDA-approved therapies.

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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. US FDA granted fast track designation for pritelivir in 2017 and breakthrough therapy designation 2020. PAPER By: Carta, Fabrizio ; et al.

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