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Wednesday, August 27, 2025
TopicUSFDA

Topic: USFDA

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.

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.

On Camera

India will absorb Trump tariff impact due to its Achilles’ heel

Like China, India remains a big domestic market, which will continue to attract investment, but the US tariffs will make India unattractive for future investments.

New insolvency frameworks to shorter timelines, how 2025 amendment bill proposes to transform IBC

New bill aims to fix key issues with IBC 2016, including delays & patchy implementation, and protect creditors, with window for genuine promoters to retain control of their companies.

Op Sindoor lesson: IAF chief bats for joint planning & coordination centre in Delhi, not theaterisation

Contrary to claims regarding implementation of theaterisation, ThePrint first reported on 17 June 2021 that it will be delayed. Now, ACM Singh bats for different structure.

That Oval Office picture for ages deserves closer Indian reading, with a geopolitical lens

Putin sees this as a victory. Europeans have decided to deal with Trump on his terms for the sake of the larger Western alliance. We look at the lessons for us in India.