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Monday, November 24, 2025
TopicFDA

Topic: FDA

US FDA is setting a higher bar for emergency Covid vaccine approvals

FDA says it will need more robust data about how well a Covid vaccine works before granting an emergency waiver, building on guidelines that say it should be at least 50% effective.

Why big pharma needs to do more to counter Covid vaccine politics

9 Covid vaccine developers signed a pledge saying they won't submit their inoculations for Food & Drug Administration approval until they show safety & efficacy in late-stage trial.

Convalescent plasma therapy holds promise, but here’s why scientists are still studying it

US approves emergency use of convalescent plasma to treat Covid-19, but studies conducted so far don't hold enough evidence to prove it works effectively and without risk. 

US FDA expands use of plasma therapy to treat Covid patients

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

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

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

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

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

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

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.

On Camera

DPDP Act will change how we interact with the internet. Get ready for the consent mails

India does not have a data protection regulator to make good on the DPDP Act’s promise and articulate clear future standards.

At Charcha 2025: Local entrepreneurship, not just big IT, will drive next wave of distributed AI work

While global corporations setting up GCCs in India continue to express confidence in availability of skilled AI engineers, the panel argued that India’s real challenge lies elsewhere.

US pilot says his team pulled out of Dubai Air Show after Tejas crash out of respect for IAF pilot

Taylor ‘Fema’ Hiester, commander of USAF F-16 Viper Demo Team, hit out at air show organisers for continuing with the show after Wing Commander Namansh Syal lost his life in the incident.

A tribute to Tejas. India’s delay culture is the real enemy in the skies

It is a brilliant, reasonably priced, and mostly homemade aircraft with a stellar safety record; only two crashes in 24 years since its first flight. But its crash is a moment of introspection.