The European Commission has granted Esperion approval for Nilemdo, the company has sold commercialisation rights to Daiichi Sankyo.
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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.
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.
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.
The MHRA and Council of Europe have both announced measures to prevent the spread of falsified or unlicensed COVID-19 medical products.
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.
A new treatment called APR-OD031 has been given Orphan Drug Designation (ODD) by the FDA, for the treatment of phenylketonuria.
The European Medicines Agency has released recommendations about which patients could benefit from remdesivir and the possible criteria for compassionate use of the drug.
New reports say that India will stock up on personal protective equipment and ventilators by banning exports and importing from China.
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.
The EMA has published its regulatory strategy until 2025, highlighting that it will use the COVID-19 pandemic to adapt its processes as needed.
The US FDA has announced that all manufacturers should withdraw their ranitidine products from the market due to the risks associated with NDMA impurities.
Cenobamate’s application was based on a global clinical trials programme enrolling over 1,900 adults with uncontrolled focal-onset seizures.
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.
With concerns rising about medicine availability during the global COVID-19 coronavirus pandemic, European Pharmaceutical Review explores how the pharmaceutical supply chain is faring.