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New harmonised guidance for post-approval changes released by FDA
The FDA has published its finalised guidance for drug lifecycle management, including an improved framework for the management of post-approval changes.
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US Food and Drug Administration (FDA)
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CBD tablet significantly improves diabetic peripheral neuropathic pain
In a Phase II trial, a cannabidiol (CBD) sublingual tablet reduced pain scores in patients with diabetic peripheral neuropathy by approximately 50 percent.
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FDA outlines plan for making inspections more consistent going forward
The new report shows over 8,000 planned inspections were postponed due to COVID-19 and outlines the FDA’s plan for a more consistent future state of operations.
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FDA allows Pfizer’s COVID-19 vaccine to be used in adolescents
The Comirnaty® vaccine’s emergency use authorisation has been extended to allow its administration to those 12 years of age and above in the US.
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MDMA-assisted therapy successful in PTSD patients
Three sessions of MDMA-assisted talk therapy resulted in significant symptom reductions for 88 percent of patients with severe, chronic post-traumatic stress disorder (PTSD).
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How small medical device manufacturers can achieve cost-effective compliant labelling
Susan Gosnell, product manager at NiceLabel, explores the potential labelling compliance issues for small medical device manufacturers and discusses how cloud labelling solutions could help combat them.
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AstraZeneca’s Tagrisso: first medicine approved in the UK under Project Orbis
Tagrisso (osimertinib) was approved for an indication extension after it reduced risk of death by over 80 percent in certain early-stage non-small cell lung cancer patients.
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Remestemcel-L reduces ARDS mortality in those under 65 years old
New data shows patients with COVID-19-related Acute Respiratory Distress Syndrome (ARDS) were up to 75 percent less likely to die when treated with remestemcel-L and dexamethasone.
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Cell-based seasonal influenza vaccine safe and effective in children
Phase III data shows Seqirus’ cell-based quadrivalent seasonal influenza vaccine was as effective and safe as an equivalent FDA-approved egg-based vaccine in paediatric patients.
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Acceleron receives FDA Notice of Noncompliance
The Notice of Noncompliance gives Acceleron 30 days to submit the required clinical trial results information to ClinicalTrials.Gov or face financial penalties.
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First patient dosed with dalbavancin in S. aureus bacteremia trial
The trial will assess the efficacy of a two week regimen of the FDA-approved antibiotic dalbavancin in treating 100 patients with Staphylococcus aureus bacteremia.
![Two vials labelled 'Janssen COVID-19 Vaccine' [Credit: oasisamuel/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Janssen-COVID-19-Vaccine-300x278.jpg)
![Two vials labelled 'Janssen COVID-19 Vaccine' [Credit: oasisamuel/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Janssen-COVID-19-Vaccine-e1619436264802.jpg)
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Janssen COVID-19 Vaccine approved for continued use in US
The US FDA and CDC have confirmed that the single-shot COVID-19 vaccine’s benefits continue to outweigh the risks of clotting and have given approval for its use to resume.
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Further woes for Emergent’s Bayview vaccine production facility
An FDA inspection identified nine concerns including unsanitary conditions and ineffective practices for preventing cross-contamination at Emergent’s facility.
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FDA approves Jemperli for advanced endometrial cancer
Jemperli (dostarlimab) was granted accelerated approval after 42.3 percent recurrent or advanced endometrial cancer patients with deficient mismatch repair responded in a trial.
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Discussing developments in RMM with Dr Tim Sandle, Bio Products Laboratory
In this video, Dr Tim Sandle explains how COVID-19 has impacted the application of rapid microbial methods (RMM) and much more...
