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Thursday, April 25, 2024
TopicUSFDA

Topic: USFDA

Indian pharma firms Zydus, Alembic recall 2 drugs in US over ‘life-threatening’ consequences

Zydus Cadila recalls injection for treatment of herpes infections over complaints of crystallisation in vials, Alembic Pharmaceuticals recalls its high BP drug due to labelling error.

US FDA panel recommends emergency approval of Moderna Covid vaccine

FDA's committee at its meeting Thursday voted 20-0 with one abstention to recommend Emergency Use Authorization for the Moderna COVID-19 vaccine mRNA-1273.

US approves first at-home, over-the-counter Covid test, calls it ‘major milestone’

Made by Australia-based Ellume, the single-use nasal swab test is small enough to fit in the palm of a hand and delivers results in 15 minutes.

US FDA approves Pfizer Covid vaccine for emergency use

It’s still unclear whether the vaccine, which was cleared by UK health regulators last week, is effective at preventing Covid-19’s spread, according to the FDA staff report.

First at-home Covid test gets approval — what this means, its impact & if it’s good news

USFDA Tuesday issued an emergency use authorisation to Lucira Health Inc.’s rapid-result Covid test, the first that can be used at home. Here's all you'd like to know about it.

USFDA approves first at-home test kit for detecting Covid

While some Covid tests allow people to to mail in samples collected at home, this is the first that can be fully self-administered & provides results at home in 30 minutes or less.

Eli Lilly’s Covid antibody drug gets emergency-use clearance by USFDA

The clearance gives doctors an option for tackling the coronavirus in high-risk patients before they’re sick enough to require hospitalization.

‘Deep state’ FDA is taking a beating as review of Covid vaccine approaches

At a time when the FDA needs the public’s trust more than ever, the US agency has been dragged into the political fray in a series of compounding incidents.

FDA wasn’t wrong in allowing plasma therapy for Covid patients in US

FDA's decision set off a media firestorm, with politicians, public-health officials & medical professionals insisting that the Trump administration was playing politics with science.

US FDA rows back on plasma therapy, says it doesn’t give dramatic benefit to Covid patients

FDA Commissioner Stephen Hahn had said Sunday that blood plasma from Covid-19 survivors given to new patients could save huge numbers of lives.

On Camera

Imtiaz Ali obsesses over vulgarity, misses Chamkila’s cultural resistance against purity

Peter Manuel's ‘Cassette Culture’ showed the booming Bhakti music during the '80s and '90s when Anoop Jalota, Gulshan Kumar achieved success by singing the sanitised Bhajans.

Economists vs statisticians — the battle being fought over the soul of India’s GDP data

Economists say there are weaknesses in India’s GDP data. But statisticians claim the accusations are based on flawed understanding, saying while GDP has problems, the economists are looking in the wrong places.

India and Japan hold 10th round of consultations on disarmament, non-proliferation, and export control

The two sides also discussed ways to strengthen cooperation in outer space security, conventional weapons, and export control

These 6 states are key for Modi’s ‘400 paar’ target. They’re also where Opposition can stop him

While this contest looks so predictable in large swathes of our political landscape, it is also more keenly contested than 2019 in some states.