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Recent Advances in FDA-Approved Kinase Inhibitors Targeting Lung Cancer
Lung cancer is a chronic deadly disease and is implicated with highest mortality rate among all cancers since years. Kinase are the...
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Viltolarsen: From Preclinical Studies to FDA Approval
Viltolarsen is a phosphorodiamidate morpholino antisense oligonucleotide (PMO) designed to skip exon 53 of the DMD gene for the treatment of Duchenne...
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The Role of Model Master Files for Sharing, Acceptance, and Communication with FDA
With the evolving role of Model Integrated Evidence (MIE) in generic drug development and regulatory applications, the need for improving Model...
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Recent Advances in FDA-Approved Kinase Inhibitors Targeting Lung Cancer
Lung cancer is a chronic deadly disease and is implicated with highest mortality rate among all cancers since years. Kinase are the...
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Pharmacological Profile of FDA-Approved Orphan Drugs in the Year 2022
Purpose of ReviewThis manuscript aimed to provide a scientific report of recently FDA-approved orphan drugs for hel** patients, researchers,...
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Synthesis and clinical application of new drugs approved by FDA in 2022
The pharmaceutical industry had a glorious year in 2022, with a total of 37 new drugs including 20 new chemical entities (NCEs) and 17 new biological...
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A Review of the Current FDA-Approved Antibody-Drug Conjugates: Landmark Clinical Trials and Indications
Despite considerable treatment progress, cancer remains among the leading causes of death worldwide. Antibody-drug conjugates (ADCs), a rapidly...
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A Communication Effectiveness Study of the FDA GMP Warning Letters
PurposeStudy the structure and content trend over time of the FDA GMP Warning Letters for their roles in effective communication.
Methods ...
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A review of the clinical efficacy of FDA-approved antibody‒drug conjugates in human cancers
While strategies such as chemotherapy and immunotherapy have become the first-line standard therapies for patients with advanced or metastatic...
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Partnering with the FDA
The US Food and Drug Administration (FDA) has existed for more than 150 years, traced back to the creation of the Agricultural Division in 1848....
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Discovery of SARS-CoV-2 Antiviral Drugs Through Large-Scale Virtual Screening of FDA-Approved Drugs
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the etiological agent responsible for the viral pneumonia outbreak of coronavirus...
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Trends in the approval of cancer therapies by the FDA in the twenty-first century
The cancer treatment landscape has changed dramatically since the turn of the century, resulting in substantial improvements in outcomes for...
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Patterns of toxicity burden for FDA-approved immune checkpoint inhibitors in the United States
BackgroundImmune-related adverse events (irAEs) are a common phenomenon in cancer patients treated with immune checkpoint inhibitors (ICIs)....
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Patient In-Use Stability Testing of FDA-Approved Metformin Combination Products for N-Nitrosamine Impurity
Between February 2020 and January 2022, the Food and Drug Administration (FDA) recalled 281 metformin extended-release products due to the presence...
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FDA Warning Letters: A Retrospective Analysis of Letters Issued to Pharmaceutical Companies from 2010–2020
PurposeTo launch a pharmaceutical product in the US market, approval from the FDA is required. Pharmaceutical companies undergo FDA pre-approval...
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FDA-approved disulfiram as a novel treatment for aggressive leukemia
AbstractAcute leukemia continues to be a major cause of death from disease worldwide and current chemotherapeutic agents are associated with...
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Dangers of FDA Oversight of Clinical Trials in Develo** Countries
Conducting more clinical trials outside the United States (US) intended to support Food and Drug Administration (FDA) approval of drugs poses a major...
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NASH: regulatory considerations for clinical drug development and U.S. FDA approval
Nonalcoholic fatty liver disease is a growing public health crisis, with phenotypes from nonalcoholic fatty liver to nonalcoholic steatohepatitis,...
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Content Analysis of US FDA Warning Letters Issued to Compounding Pharmacies Regarding Violations of Current Good Manufacturing Practices Between 2017 and 2022
PurposeAssessment of the US FDA-issued WLs content is an educational tool that can be used in the continuous training program of community...
