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FDA 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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The US Food and Drug Administration (FDA)
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Personalised 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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Limiting 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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FDA 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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Amgen 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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FDA 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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Pharmaceutical 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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Switzerland and US sign drug inspection agreement
To promote Good Manufacturing Practice, Switzerland and the US have signed a Mutual Recognition Agreement to improve pharmaceutical drug inspection.
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Eisai submits MAA for lecanemab in Europe
A Marketing Authorisation Application for lecanemab to treat Alzheimer's has been submitted to the European Medicines Agency.
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Potential blockbuster drugs to watch in 2023
Lecanemab for Alzheimer's and the first potential gene therapy primed for US launch for haemophilia A are two potential blockbuster Drugs to Watch™, says a 2023 report.
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FDA grants accelerated approval for Leqembi
Alzheimer’s drug Leqembi has been accepted via the US Food and Drug Administration (FDA)’s Accelerated Approval pathway.
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FDA accepts Biologics License Application for RSV vaccine
The Biologics License Application for nirsevimab as the first protective option against RSV for all infants has been accepted by the the US Food and Drug Administration (FDA).
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First treatment approval for advanced ASPS
A Phase II trial has led to the FDA approval of atezolizumab for individuals over two years old with advanced alveolar soft part sarcoma.
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Whole genome sequencing and analysis of live biotherapeutic products
Here, Snehit Satish Mhatre and Michael Timm of Eurofins discuss considerations and recommendations for the testing of live biotherapeutic products.
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The potential of tryptamines in treatment-resistant depression
There is growing interest in the use of psychedelic-assisted therapy for treatment of mental health conditions. Here, Guy Goodwin, Chief Medical Officer of COMPASS Pathways, explores the potential of tryptamines to treat depression, sharing results from a recent clinical trial.
