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Sunday, November 2, 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

Organ donation does not end with surgery. India must help recipients, donors survive

Even under optimal care, post-operative vigilance is non-negotiable. Yet patients are left to navigate this challenge alone.

Consumer Price Index gets up to date. Airfare, OTT plans, e-commerce prices in new basket—MoSPI secy

New CPI series will take 2024 as base year, will provide more accurate measure of inflation, spending on digital services. Expected to enhance representation and reliability, says Saurabh Garg.

Joint production, closer ties, emerging tech: The foundation of new defence pact between India & US

The agreement, signed after meeting between Rajnath and US Secretary of War Pete Hegseth on sidelines of ADMM-Plus in Kuala Lumpur, aims to deepen bilateral ties in the critical sector.

Trump’s trade wars have rewritten powerplay, but India didn’t get the memo

This world is being restructured and redrawn by one man, and what’s his power? It’s not his formidable military. It’s trade. With China, it turned on him.