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FDA sends two warnings to companies selling unapproved CBD products
Two companies selling unapproved cannabidiol (CBD) products including for the treatment of opioid addiction, have been handed warning letters from the FDA.
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US Food and Drug Administration (FDA)
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Nanoparticle delivery offers a possible alternative to opioid pain relief
An international team of researchers has used nanoparticles to deliver a drug – one that previously failed in clinical trials for pain – into specific compartments of nerve cells, dramatically increasing its ability to treat pain in mice and rats. Nikki Withers spoke to Nigel Bunnett to hear more about…
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The importance of continually evolving solid dosage forms
Solid dosage forms have been one of the foremost choices of drug administration for generations. However, with an ever-growing global population, evolving customer demands and continual updates to regulations comes greater need for advanced medicines and progress in this sector. This article explores the benefits and how the field must…
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Fresenius Kabi recalls 13 lots of ketorolac tromethamine injection
The FDA has announced that Fresenius Kabi is voluntarily recalling 13 lots of ketorolac tromethamine injection due to particulate matter found in reserve sample vials.
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Emerging biotechs tackle medical research continuity concerns amid COVID-19
While medical professionals fight COVID-19 on the front line, small biotech businesses face a new uphill battle – maintaining research continuity for non-COVID-19 life-changing therapeutics.
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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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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.
