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FDA

Moderna files for full US approval of COVID-19 vaccine
World

Moderna files for full US approval of COVID-19 vaccine

  • The development comes weeks after rival Pfizer Inc and its German partner BioNTech SE sought full approval for their COVID-19 vaccine in the United States.
  • Moderna said it will continue to submit data to the US Food and Drug Administration on a rolling basis over the coming weeks with a request for a priority review.
Published 01 Jun, 2021 07:14pm
Johnson & Johnson's one-shot COVID-19 vaccine effective and safe
World

Johnson & Johnson's one-shot COVID-19 vaccine effective and safe

  • J&J said in documents submitted to the FDA that its data suggested its vaccine was effective at preventing asymptomatic infections.
  • J&J's vaccine was 66% effective in preventing COVID-19 against multiple variants in a global trial involving nearly 44,000 people, the company said last month.
Published 24 Feb, 2021 07:32pm
US FDA extends review period for Biogen's Alzheimer's drug
Business & Finance

US FDA extends review period for Biogen's Alzheimer's drug

  • Our key takeaway is that if the FDA would have wanted to reject the drug, we would have heard the decision by now.
  • The road to getting a regulatory nod for the drug has been rocky, with the companies scrapping two studies of the therapy in March 2019, and reversing that decision a few months later.
Published 29 Jan, 2021 07:14pm