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Friday, October 31, 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

Starbucks was once progressive. It’s now approaching a dangerous spot in culture wars

Former CEO Howard Schultz once told shareholders those who opposed his support of same-sex marriage were free to invest elsewhere. But now, CEO Brian Niccol seems to be selling Starbucks as a place that just, well, sells coffee.

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.

India pulled out of Tajikistan’s strategically important Ayni air base in 2022. Here’s why

Tajikistan did not want to extend the lease because of apparent pressure from Russia & China over non-regional military personnel at the air base, it is learnt.

Deepfake on duty: when I asked AI to read Op Sindoor citations

On 21 Oct, a buzz went up that the govt had released full list of gallantry award recipients along with Op Sindoor citations. I put an AI caddy on the job. It took me into a never-ending rabbit hole.