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Thursday, November 20, 2025
TopicUSFDA

Topic: USFDA

World’s 1st vaccine against chikungunya primed for launch in India, says French drugmaker Valneva

VLA1553, commercially known as Ixchiq, has received USFDA clearance and will be launched in India — which has seen high number of chikungunya cases — after ‘regulatory talks with DCGI’.

Cure for sickle cell disease on the horizon? US drug regulator is reviewing 2 new gene therapies

FDA is scheduled to review gene therapies from two American companies — Vertex Pharmaceuticals & Bluebird Bio Inc. If approved, therapies could mean a breakthrough for curing SCD.

Calls for caution over phenylephrine’s efficacy, as FDA panel deems decongestant ineffective

Panel report notes that oral phenylephrine is no better than placebo for relieving nasal congestion. In India, phenylephrine is widely used in cough and cold medicines.

All about Leqembi, new Alzheimer’s drug that’s likely to get US approval, and its risks

If it gets FDA's nod this week, it will be the second in a new category of medications to treat mild to moderate cases of the neurodegenerative disease in the US.

Covaxin to be evaluated as Covid-19 vaccine candidate in US as FDA lifts clinical hold

As many as 110 countries have agreed to mutual recognition of Covid-19 vaccination certificates with India that includes vaccination using Covaxin.

US approves Alzheimer’s drug for first time in 20 yrs. What is it & why it is controversial

US FDA has approved Aduhelm drug, which proposes to work by chipping away at protein deposits in the brain that cause memory loss and other symptoms of Alzheimer’s.

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.

On Camera

Hasina’s was a trial in absentia, but not a trial without justice

The Sheikh Hasina trial represents an inflection point in the struggle to place citizens above rulers and prevent the next massacre.

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.

Can’t stay behind tech curve anymore, must catch up—Vice Chief of Navy Staff ahead of Swavlamban 2025

New Delhi: Noting that India cannot afford to stay behind the technology curve when it comes to war-fighting, Vice Chief of the Naval Staff...

INDIA has a Congress-sized hole. And the fix begins with a little humility

Without a Congress revival, there can be no challenge to the BJP pan-nationally. Modi’s party is growing, and almost entirely at the cost of the Congress.