FDA Approvals

FDA Approvals

FDA Approval of Immunotherapy Drugs Brings Hope to Mesothelioma Patients

The drugs—nivolumab and ipilimumab—have now been approved by the FDA for first-line treatment of adult patients who suffer from malignant pleural mesothelioma.

Oncology Times - Latest Articles
The quality of reporting general safety parameters and immune-related adverse events in clinical trials of FDA-approved immune checkpoint inhibitors

This methodological review compared the quality of reporting of safety information and in particular, serious irAEs, in publications and ClinicalTrials.gov for all current FDA-approved ICIs.

BMC Cancer

FOCR Meeting Highlights Modernization of Expedited FDA Drug Approvals

The Friends of Cancer Research held the first of a two-part virtual annual meeting, which focused on ways of updating expedited drug approvals at the FDA.

Oncology Times - Latest Articles
A New Strategy in Treating Patients With CAR T-Cell Therapy

A novel “switchable” CAR T-cell therapy for blood cancers moved into early clinical trials recently after gaining Fast Track designation from the FDA. 

Oncology Times - Latest Articles
FDA and EMA Approvals of New Breast Cancer Drugs-A Comparative Regulatory Analysis.

This study examines new drug approvals for breast cancer by the FDA and the EMA, based on an analysis of regulatory documents from both agencies for the period from 1995 to 2018.

Comparison of FDA accelerated vs regular pathway approvals for lung cancer treatments between 2006 and 2018.

The aim of this study is to compare FDA Accelerated vs Regular Pathway approvals and BTD for lung cancer treatments between 2006 and 2018 regarding...

Timing of US Food and Drug Administration (FDA) cancer drug approvals relative to publication of clinical trial results.

Publication of clinical trial results in peer reviewed literature is essential to inform clinicians regarding the use of new anti-cancer treatments, which often have a low therapeutic ratio...

Journal of Clinical Oncology
Predicting Regulatory Product Approvals Using a Proposed Quantitative Version of FDA's Benefit-Risk Framework to Calculate Net-Benefit Score and Benefit-Risk Ratio.

Approval of regulated medical products in the USA is based upon a rigorous review benefits and risks as performed by US FDA staff scientists summarized descriptive qualitative format called...

Therapeutic Innovation &amp
FDA Approvals and Consensus Guidelines for Botulinum Toxins in the Treatment of Dystonia.

In 2016, the American Academy of Neurology (AAN) published practice guidelines for botulinum toxin (BoNT) in treatment blepharospasm, cervical dystonia, adult spasticity, and headache.

FDA's Benefit-Risk Framework for Human Drugs and Biologics: Role in Benefit-Risk Assessment and Analysis of Use for Drug Approvals.

Structured, descriptive approaches are utilized by drug regulatory agencies to support and communicate approval decisions about human drugs biologics.

Therapeutic Innovation &amp
2019 in review: FDA approvals of new medicines.

53 146 2018 The US Food and Drug Administration (FDA) green-lighted the marketing of therapeutic agents in 2019. This rate approvals was consistent with 5-year running average.

Drug Discovery Today

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