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EMA releases its regulatory strategy for next five years
The EMA has published its regulatory strategy until 2025, highlighting that it will use the COVID-19 pandemic to adapt its processes as needed.
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Dr Reddy’s recalls four lots of Phytonadione injectable emulsion in US
The FDA has announced that Dr Reddy's is recalling Phytonadione injectable emulsion because of complaints due to ampules breaking and shattering.
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Two Phase III trials to study remdesivir in COVID-19 patients initiated
Gilead Sciences has announced that two Phase III studies to test the safety and efficacy of remdesivir in COVID-19 patients have begun.
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How is liquid chromatography used in the pharmaceutical industry?
Liquid chromatography is an analytical technique utilised widely in the pharmaceutical industry. How does it work and what other methods can it be combined with to enhance its uses?
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FDA requests recall of all ranitidine products on US market
The US FDA has announced that all manufacturers should withdraw their ranitidine products from the market due to the risks associated with NDMA impurities.
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MHRA issues Class 4 Medicines Defect Information for paracetamol
A barcode for paracetamol 250mg/5ml oral suspension displays the wrong strength when scanned, prompting the MHRA to announce the defect information.
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EMA accepts marketing authorisation application for anti-epileptic drug cenobamate
Cenobamate’s application was based on a global clinical trials programme enrolling over 1,900 adults with uncontrolled focal-onset seizures.
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How to take care of your mental health during the COVID-19 pandemic
During the COVID-19 pandemic, when many are in lockdown or self-isolating, mental health could suffer. This article suggests some ways to stay healthy over this period.
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J&J says clinical trials for COVID-19 vaccine candidate will begin by September
Following the selection of a COVID-19 vaccine lead, Johnson & Johnson (J&J) aims to begin clinical trials in humans later this year while also scaling up its manufacturing facilities.
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EMA warns consumers about falsified COVID-19 drugs from online pharmacies
The European Medicines Agency (EMA) has advised consumers on how to recognise registered online pharmacies so they can avoid falsified medications.
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Female directors are quicker to recall defective medicinal products, finds study
The presence of female directors makes boards more likely to report lower-severity defects and faster to recall products with high-severity problems, suggests research.
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EMA advises continued use of hypertension drugs during COVID-19 pandemic
The EMA has said that patients should continue to use angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs), despite reports that these worsen COVID-19 infections.
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Global trial to evaluate Kevzara® (sarilumab) as COVID-19 therapy initiated
A Phase II/III trial to study Kevzara (sarilumab) as a method to reduce the inflammatory response in the lungs of COVID-19 patients has begun outside of the US.
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FDA approves Zeposia® (ozanimod) to treat relapsing forms of multiple sclerosis
The US FDA has granted approval to BMS for Zeposia, a once daily oral medication for the treatment of relapsing forms of multiple sclerosis.
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Committee for Medicinal Products for Human Use (CHMP) meeting highlights
A summary of the CHMP meeting conclusions, including medicines recommended for approval and indication extension and several safety review findings.