TopicFDA

Topic: FDA

US FDA expands use of plasma therapy to treat Covid patients

Jordan Fabian - August 24, 2020

The move will make it easier to receive the treatment, which Trump has promoted even though studies to prove its benefits haven’t been completed.

US drug authority could allow emergency use of plasma therapy for Covid-19, reveals report

Mohana Basu - July 30, 2020

While several clinical trials are underway across the world to test the efficacy of convalescent plasma therapy, the results from these studies are limited.

US FDA wants a coronavirus vaccine that really works

Max Nisen - July 2, 2020

The new guidance sets out a broad set of potential trial goals, ranging from preventing severe disease to stopping infection outright.

Why America is unlikely to get a coronavirus vaccine before early 2021

Cristin Flanagan - July 2, 2020

While investors expected the first vaccine to arrive before November, analysts don't see a vaccine being approved before 2021 given FDA's guidelines.

US FDA revokes authorisation given for emergency use of HCQ to treat Covid

Anna Edney - June 16, 2020

Chloroquine and hydroxychloroquine ‘are unlikely to be effective in treating Covid-19’, the US Food and Drug Administration said.

Indian drugmaker Lupin voluntarily recalls metformin variant, a diabetes drug, in US

Himani Chandna - June 12, 2020

India has said it is monitoring the US FDA updates, which said an extended-release variant of the drug had higher levels of a cancer-causing substance.

US grants emergency approval to at-home sample collection kit for Covid-19 test

Himani Chandna - May 17, 2020

The new Covid-19 test kit allows a patient to self-collect a nasal swab and send it to lab. The process will take three to five days.

Priced at $5 and taking just minutes, new antigen test in US could be Covid ‘game-changer’

Jennifer Dlouhy - May 11, 2020

The move could mark a breakthrough in screening for the coronavirus as health professionals argue that swift screening is essential to temper new outbreaks.

Top members of US coronavirus task force go into quarantine after exposure to virus

Jennifer Dlouhy - May 10, 2020

US FDA Commissioner Stephen Hahn & CDC Director Robert Redfield's exposure comes days after several aides working in the White House tested positive for the virus.

US grants emergency approval to Roche antibody test that can deliver result in 18 mins

Tim Loh - May 4, 2020

Swiss company Roche Holding AG said the test runs on a high-volume instrument that can give as many as 300 results in an hour.

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Topic: FDA

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