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J&J Submits Single Dose COVID-19 Vaccine to FDA

J&J Submits Single Dose COVID-19 Vaccine to FDA

Feb 5, 2021 | FDA, News, Regulatory

Janssen Biotech, a Johnson & Johnson company, submitted an Emergency Use Authorization (EUA) application to the U.S. Food and Drug Administration (FDA) for its single dose COVID-19 vaccine. The submission is based on topline safety and efficacy data from the Phase...
Moderna’s COVID-19 Vaccine Approved by Singapore

Moderna’s COVID-19 Vaccine Approved by Singapore

Feb 4, 2021 | News, Regulatory

Singapore has become the first Asian country that has approved the Moderna COVID-19 vaccine as it begins its efforts in implementing its immunization program. The first shipment of Moderna’s vaccine is expected sometime around March. Currently, 175,000 of Singapore’s...
Sputnik V Vaccine Efficacy Validated by Peer Review

Sputnik V Vaccine Efficacy Validated by Peer Review

Feb 2, 2021 | News, Regulatory

Despite facing much public scrutiny for rushing the Sputnik V vaccine, the efficacy of Russia’s vaccine has been validated in a peer-reviewed study that was published in The Lancet. The Lancet published an interim analysis of Phase III data that Sputnik V has...
FDA Places Mexican Hand Sanitizers on Import Alert

FDA Places Mexican Hand Sanitizers on Import Alert

Jan 28, 2021 | News, Regulatory

For the first time in history, the U.S. Food and Drug Administration (FDA) has placed a countrywide import alert for all hand sanitizers from Mexico due to concerns of methanol contamination. Hand sanitizers that are contaminated with methanol are known to result in a...