Initial results suggest NT-300 (nitazoxanide extended-release tablets, 300mg) reduces progression to severe illness in mild to moderate COVID-19 patients.
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The FDA and CDC have decided to temporarily suspend use of Janssen’s single dose vaccine while reports of rare and severe blood clots are investigated.
The observatory will collate drug safety data, analyses and decisions into a single source to help pharma identify regional differences in decision-making.
The combination was approved on Phase III trial results which show it doubled progression-free survival and reduced risk of death by 40 percent, compared to standard of care.
Abecma (idecabtagene vicleucel) was approved for adults with relapsed or refractory myeloma based on its 72 percent overall response rate in a trial.
The warning letters were issued to two companies illegally selling over-the-counter cannabidiol (CBD) products for pain relief.
The Tiger Tech COVID Plus Monitor was granted Emergency Use Authorization (EUA) based on its ability to detect biomarkers indicative of COVID-19 infection in asymptomatic individuals.
The Garnet™ therapeutic product, which can capture more than 100 clinically relevant bacteria, fungi, parasites, toxins and viruses from the blood, will soon begin clinical testing.
European Pharmaceutical Review’s Hannah Balfour outlines the findings of market research reports exploring the challenges and drivers for the pharmaceutical packaging equipment market between 2020 and 2025.
In this article, Dr Ronan Brown, IQVIA’s SVP and Head of Integrated Global Compliance, explores the long-term impact of COVID-19 on regulatory practices in three key areas: clinical trial study design, clinical trial study development and post-clinical trial regulatory submissions.
New research shows a second COVID-19 vaccine dose may be unnecessary in individuals previously infected with SARS-CoV-2 and needlessly exposes individuals to higher rates of adverse effects.
Moderna has begun testing two new mRNA COVID-19 vaccines, one specifically targeting the B.1.351 variant and the other a multivalent candidate.
In a high-risk patient cohort, treatment with the combination of bamlanivimab and etesevimab reduces COVID-19 related hospitalisation and death by 87 percent.
The PCR based Alinity™ m Resp-4-Plex molecular assay can detect and differentiate SARS-CoV-2, influenza A, influenza B and respiratory syncytial virus (RSV).
In clinical testing, the T-SPOT.COVID test was found to agree with PCR test results in over 96 percent of samples taken within first 60 days of infection.