news
US researchers to study stem cell therapy in COVID-19 patients
The FDA has approved a clinical trial to study COVID-19 patients administered with umbilical cord-derived mesenchymal stem cells, which should prevent lung inflammation.
List view / Grid view
US Food and Drug Administration (FDA)
article
COVID-19: regulatory implications for the UK and European life sciences industry
Marie Manley and co-authors from Sidley Austin explain the updates to regulations in the EU and UK in light of the COVID-19 coronavirus pandemic.
news
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.
article
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.
news
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.
news
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.
news
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.
news
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.
news
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.
article
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.
news
FDA and EMA offer updates on COVID-19 treatments and vaccines in development
The FDA and EMA have announced which COVID-19 treatments and vaccines are currently in development, as well as how they are supporting clinical trials.
news
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.
news
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.
news
Over 90 percent of medical marijuana in US contains high levels of THC, study finds
A study conducted in the US has revealed that the majority of medical marijuana dispensed in the US has THC levels of up to 15 percent.
news
Indian government ceases exports of Ipca (hydroxychloroquine)
India has stopped exporting the malaria drug Ipca (hydroxychloroquine), despite the FDA lifting its ban on imports due to its potential as a coronavirus treatment.
