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FDA accelerates approval of Trodelvy to treat triple-negative breast cancer
The US FDA has granted accelerated approval of Trodelvy (sacituzumab govitecan-hziy), to treat triple-negative breast cancer in adult patients.
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US Food and Drug Administration (FDA)
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FDA approves IMBRUVICA® (ibrutinib) for treatment of chronic lymphocytic leukaemia and small lymphocytic lymphoma
IMBRUVICA (ibrutinib), in combination with rituximab, has been given approval in the US for the treatment of chronic lymphocytic leukaemia and small lymphocytic lymphoma.
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The COVID-19 pandemic and the Indian pharmaceutical industry
Dr Abhishek Dadhich rounds up how the Indian pharmaceutical market has been impacted by the coronavirus pandemic and the steps the country’s government could take to overcome these setbacks.
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IND submitted for opaganib, potential COVID-19 treatment
RedHill Biopharma has submitted its Investigational New Drug application for its drug opaganib, for the treatment of COVID-19, to the FDA.
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Amneal recalls three nizatidine lots due to potential NDMA contamination
The FDA has said that Amneal Pharmaceuticals is recalling three lots of nizatidine oral solution at the consumer level due to potential NDMA contamination.
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Stem cells in the clinic: how are they regulated?
Dr Roger Barker, University of Cambridge, UK and Eric Anthony, International Society for Stem Cell Research (ISSCR), describe how stem cells are regulated around the world and why this is important for patient safety.
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FDA approves first generic albuterol sulfate metered dose inhaler
The generic Proventil HFA (albuterol sulfate) metered dose inhaler has been approved for the prevention of bronchospasm in patients four years of age and older.
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Cutting the financial and time costs of regulatory affairs with automation
An exploration of how automation tools and AI could revolutionise the regulatory affairs sector with Ronan Brown, Senior Vice President and Head of Integrated Global Compliance at IQVIA.
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Siltuximab – testing a potential COVID-19 therapy
Interim results from the SISCO study at the Papa Giovanni XXIII Hospital in Italy have demonstrated the promise of siltuximab as a treatment for the symptoms of COVID-19. Lee Morley explains how the drug works and the next steps for its development.
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Environmental monitoring breaches at facility prompts FDA letter
The FDA has handed a warning letter to an Indian manufacturing facility for inadequate sterility testing and environmental monitoring.
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FDA grants emergency use authorisation to blood purification system for COVID-19
A blood purification system to reduce cytokine storms in COVID-19 patients has been given emergency use authorisation by the FDA.
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US researchers to study stem cell therapy in COVID-19 patients
The FDA has approved a clinical trial to study COVID-19 patients administered with umbilical cord-derived mesenchymal stem cells, which should prevent lung inflammation.
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COVID-19: regulatory implications for the UK and European life sciences industry
Marie Manley and co-authors from Sidley Austin explain the updates to regulations in the EU and UK in light of the COVID-19 coronavirus pandemic.
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FDA warns company selling fraudulent COVID-19 products containing chlorine dioxide
The US Food and Drug Administration (FDA) issued the letter after finding the products contain chlorine dioxide, a powerful bleaching agent with potentially fatal side effects.
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COVID-19 update: running clinical trials during the coronavirus pandemic
In the face of the coronavirus pandemic, restrictions and extreme situations may require changes to ongoing or upcoming clinical trials. These are the key recommendations from the EC, MHRA and FDA.
