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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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US Food and Drug Administration (FDA)
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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.
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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.
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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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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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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.
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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.
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Developers request revocation of remdesivir’s ODD for COVID-19
Gilead Sciences say they are confident they can maintain an expedited regulatory review timeline for remdesivir as a treatment for COVID-19 without Orphan Drug Designation (ODD).
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FDA hands Boehringer and Lilly complete response letter for insulin adjunct
Boehringer Ingelheim and Eli Lilly have received a complete response letter from the US FDA for their sNDA of empagliflozin 2.5mg, an insulin adjunct.
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Indian drug manufacturing facility issued FDA warning letter
Windlas Healthcare Private Ltd has been sent a warning letter by the FDA for violations of current good manufacturing practice regulations.
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Regulatory responses to the COVID-19 coronavirus
European Pharmaceutical Review brings you the latest updates from regulatory bodies across the globe in response to the COVID-19 coronavirus.
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FDA transitions to new regulatory pathway for biosimilars
The US FDA will now approve biosimilars via a new regulatory pathway to help grow the competition between biologic products.
