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US Food and Drug Administration

Pfizer COVID-19 shot 91pc effective in updated data, protective against South African variant
World

Pfizer COVID-19 shot 91pc effective in updated data, protective against South African variant

  • The shot was also 100% effective in preventing illness among trial participants in South Africa, where a new variant called B1351 is dominant, though the number of those participants was relatively small at 800.
  • While the new overall efficacy rate of 91.3% is lower than the 95% originally reported in November for its 44,000-person trial, a number of variants have become more prevalent around the world since then.
Published 01 Apr, 2021 06:23pm
US FDA approves J&J's multiple sclerosis treatment
World

US FDA approves J&J's multiple sclerosis treatment

  • The FDA approved Ponvory as a daily oral drug to treat relapsing forms of multiple sclerosis, a debilitating neurological condition in which the immune system eats away at the protective covering of nerves.
Published 19 Mar, 2021 07:06pm
Citigroup offers rapid at-home COVID-19 tests to some US staff
World

Citigroup offers rapid at-home COVID-19 tests to some US staff

  • The at-home COVID-19 testing program uses a rapid antigen test, which offers results within 20 minutes, the bank said, adding the test is awaiting emergency use approval from the US Food and Drug Administration.
  • Citi said it has offered employees at its Chicago area branches and those working on its trading floors in New York a chance to participate in the home testing program.
Published 10 Mar, 2021 07:38pm
Abbott's test to distinguish coronavirus and flu viruses gets US authorization
World

Abbott's test to distinguish coronavirus and flu viruses gets US authorization

  • The test, Alinity m Resp-4-Plex, can be conducted with one nasal swab sample and can differentiate the coronavirus, flu A, flu B and another respiratory virus called respiratory syncytial virus (RSV), the company said.
  • Abbott has a range of COVID-19 tests, including antigen, molecular and serology tests which have been authorized for emergency use by the US Food and Drug Administration.
Published 05 Mar, 2021 09:09pm
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