All The US Food and Drug Administration (FDA) articles – Page 2
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NewsFDA releases analysis on drug product quality in 2022
There continues to be a correlation between low site inspection scores and potential drug recalls, states the US Office of Pharmaceutical Quality (OPQ) 2022 annual report.
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NewsFirst cell therapy approved for Type 1 diabetes
US Food and Drug Administration (FDA)-approved allogeneic pancreatic islet cell therapy Lantidra could provide another treatment option for Type 1 diabetes.
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NewsFDA publishes recommendations on psychedelic clinical trial design
New draft guidance published by the US Food and Drug Administration (FDA) is intended to aid clinical study design in psychedelic drug development programmes.
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NewsGene therapy approved for Duchenne muscular dystrophy
The first approved gene therapy for certain paediatric Duchenne muscular dystrophy (DMD) patients leads to production of the Elevidys micro-dystrophin protein.
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NewsFirst adult anti-inflammatory cardiovascular drug approved
An FDA-approved anti-inflammatory drug can reduce cardiovascular disease risk by an additional 31 percent in adults, on top of standard of care, clinical data has shown.
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NewsFirst redosable gene therapy approved
The “landmark approval” of a redosable gene therapy for dystrophic epidermolysis bullosa “ushers in a whole new paradigm to treat genetic diseases".
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NewsFDA publishes paper on AI/ML in drug development
"rapid growth in the number of submissions that reference artificial intelligence and machine learning” has prompted the US Food and Drug Administration (FDA) to seek feedback on AI/ML in drug development.
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NewsFirst RSV vaccine approved for older adults
The US Food and Drug Administration (FDA) has approved the first-ever vaccine for respiratory syncytial virus (RSV) in adults over 60 years old.
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NewsFDA releases draft guidance for decentralised clinical trials
Recommendations on the conduct of remote clinical trial visits are included in new US Food and Drug Administration (FDA) draft guidance.
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NewsFDA approves first new B-cell lymphoma treatment in 20 years
A first-line B-cell lymphoma treatment shown to reduce the risk of disease progression or relapse by 27 percent has been approved by the FDA.
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NewsFDA approves allogeneic stem cell transplant therapy
The first allogeneic stem cell transplant therapy to be approved based on Phase III study results has been granted by the US Food and Drug Administration (FDA).
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ArticleAccelerating drug development
Here, Dave Elder explores how a ‘quick-approval, quick-withdrawal from the market’ approach is used to accelerate drug development.
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ArticleKey developments: mRNA vaccines and therapeutics
EPR summarises results from key mRNA vaccine trials, highlighting the future potential of these innovative therapeutics.
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NewsFDA approves first BTK inhibitor for lymphoma
The first BTK inhibitor of any kind approved for mantle cell lymphoma treated with a covalent BTK inhibitor, has been granted FDA approval.
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NewsPersonalised cancer immunotherapy granted fast track designation
The FDA has granted fast track designation for Evaxion’s personalised cancer vaccine in combination Keytruda® for patients with metastatic melanoma.
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NewsLimiting microbial hazards in inhaled cannabis products
FDA researchers found there was some reduction in microbial counts by heating cannabis with a commercial vaporiser to limit microbial contamination, but they were not statistically significant.
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NewsFDA issues complete response letter for donanemab
A complete response letter for Eli Lilly's accelerated approval submission of donanemab for early Alzheimer's has been issued by the US Food and Drug Administration (FDA).
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NewsAmgen commits $8m to clinical trial diversity programme
The Robert A. Winn Diversity in Clinical Trials Award Program has been pledged $8 million over the next four years by Amgen.
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NewsFDA approves long-acting injectable for schizophrenia and bipolar disorder
Schizophrenia and bipolar I disorder patients can be offered Rykindo® as a bi-weekly long-acting risperidone injection, as a result of the FDA's approval.
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ArticlePharmaceutical microbiology: key developments 2022
Here, microbiology experts Tim Sandle, Tony Cundell and AstraZeneca’s Miriam Guest reflect on key developments in pharmaceutical microbiology during 2022.
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