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EC approves Nilemdo™ (bempedoic acid) for lowering cholesterol
The European Commission has granted Esperion approval for Nilemdo, the company has sold commercialisation rights to Daiichi Sankyo.
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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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EU authorities agree new measures to support the pharma supply chain during COVID-19 pandemic
The European Medicines Agency (EMA) and other authorities have created a new shortage reporting system and are looking into how regulations can be applied more flexibly during the COVID-19 pandemic.
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British manufacturers praise UK government for relaxed hand sanitiser rules
The British Contract Manufacturers and Packers Association (BCMPA) has said the UK government's changes to expedite production of hand sanitiser will aid in the fight against COVID-19.
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UK and Europe tackle false COVID-19 medicinal products
The MHRA and Council of Europe have both announced measures to prevent the spread of falsified or unlicensed COVID-19 medical products.
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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.
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FDA grants Orphan Drug Designation to phenylketonuria treatment
A new treatment called APR-OD031 has been given Orphan Drug Designation (ODD) by the FDA, for the treatment of phenylketonuria.
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EMA recommendations on compassionate use of remdesivir for COVID-19
The European Medicines Agency has released recommendations about which patients could benefit from remdesivir and the possible criteria for compassionate use of the drug.
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India to import PPE from China in COVID-19 fight, says report
New reports say that India will stock up on personal protective equipment and ventilators by banning exports and importing from China.
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On the new EU MDR guidance for “significant change” and clinical evidence for software
Maurits Lugard, Josefine Sommer and Antoine Robin from Sidley Austin dissect the recently released EU guidance to accompany the MDR, on what a significant change is and how to collect clinical evidence for medical device software.
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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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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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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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FDA comments on President Trump’s COVID-19 Emergency Relief Bill
The bill includes $80 million funding for the US FDA to continue their COVID-19 response efforts and extra powers to modernise over-the-counter drug regulation.
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COVID-19 update: coronavirus and the pharmaceutical supply chain
With concerns rising about medicine availability during the global COVID-19 coronavirus pandemic, European Pharmaceutical Review explores how the pharmaceutical supply chain is faring.