FDA grants remdesivir emergency use authorisation to treat COVID-19
The US FDA has given emergency use authorisation to remdesivir for the treatment of patients in hospital with severe COVID-19.
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The US FDA has given emergency use authorisation to remdesivir for the treatment of patients in hospital with severe COVID-19.
There are many challenges faced by the biopharmaceutical industry in order to develop and provide sufficient drugs to treat a growing and ageing population. This article discusses whether continuous processing provides the solution.
Delivering confident QA and QC in pharmaceutical manufacturing is of critical importance. This article discusses how the latest chromatography data systems are ensuring compliance with modern regulatory requirements.
Two companies selling unapproved cannabidiol (CBD) products including for the treatment of opioid addiction, have been handed warning letters from the FDA.
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…
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…
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.
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.
The US FDA has granted accelerated approval of Trodelvy (sacituzumab govitecan-hziy), to treat triple-negative breast cancer in adult patients.
IMBRUVICA (ibrutinib), in combination with rituximab, has been given approval in the US for the treatment of chronic lymphocytic leukaemia and small lymphocytic lymphoma.
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.
RedHill Biopharma has submitted its Investigational New Drug application for its drug opaganib, for the treatment of COVID-19, to the FDA.
The FDA has said that Amneal Pharmaceuticals is recalling three lots of nizatidine oral solution at the consumer level due to potential NDMA contamination.
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.
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.