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Second COVID-19 vaccine ‘Spikevax’ is approved by the FDA
The FDA has approved a second vaccine, marketed as Spikevax,…
The FDA has approved a second vaccine, marketed as Spikevax, shown to be 93 percent effective in preventing COVID-19.
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Dr Janet Woodcock
![Gloved hand holding a vial labelled 'COVID-19 Vaccine' with Pfizer and BioNTech logos [Credit: malazzama / Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Pfizer-BioNTech-COVID-19-vaccine-300x278.jpg)
![Gloved hand holding a vial labelled 'COVID-19 Vaccine' with Pfizer and BioNTech logos [Credit: malazzama / Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Pfizer-BioNTech-COVID-19-vaccine-e1629795881701.jpg)
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Pfizer-BioNTech becomes the first FDA-approved COVID-19 vaccine
Pfizer and BioNTech's vaccine is the first to be approved…
Pfizer and BioNTech's vaccine is the first to be approved by the FDA for the prevention of COVID-19 in people aged 16 years and older.
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FDA allows additional COVID-19 vaccine dose for immunocompromised
The FDA has authorised an additional dose of COVID-19 Vaccines…
The FDA has authorised an additional dose of COVID-19 Vaccines Pfizer-BioNTech and Moderna in certain immunocompromised patients.
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FDA approves first interchangeable biosimilar insulin product
The first interchangeable biosimilar insulin product will help increase access…
The first interchangeable biosimilar insulin product will help increase access and affordability of insulin for diabetics.
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FDA outlines plan for making inspections more consistent going forward
The new report shows over 8,000 planned inspections were postponed…
The new report shows over 8,000 planned inspections were postponed due to COVID-19 and outlines the FDA’s plan for a more consistent future state of operations.
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FDA allows Pfizer’s COVID-19 vaccine to be used in adolescents
The Comirnaty® vaccine’s emergency use authorisation has been extended to…
The Comirnaty® vaccine’s emergency use authorisation has been extended to allow its administration to those 12 years of age and above in the US.
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FDA issues new guidance for developers of COVID-19 vaccines, diagnostics and therapeutics
The new recommendations address the evolving landscape of COVID-19 drug…
The new recommendations address the evolving landscape of COVID-19 drug development, including the emergence of SARS-CoV-2 variants.
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FDA requests recall of all ranitidine products on US market
The US FDA has announced that all manufacturers should withdraw…
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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FDA centres collaborate to evaluate conclusions of pharmacogenetic testing
The FDA has released a statement that two of its…
The FDA has released a statement that two of its centres will collaborate to provide information on gene-drug interactions they believe have sufficient supporting evidence.
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Statement from the FDA on NDMA found in drugs outside the US
The FDA has released a statement on the investigations into…
The FDA has released a statement on the investigations into the presence of nitrosamines in some drugs; highlighting that there are currently no recalls of metformin within the US.
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Impurity in valsartan leads to voluntary recall
Some drugs with active ingredient valsartan have been recalled due…
Some drugs with active ingredient valsartan have been recalled due to presence of impurity NMDA...
