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Tuesday, October 7, 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

Only below-the-radar diplomacy can work in India-US trade ties now

India’s competitiveness cannot be defended abroad if it is eroded at home. Short-term measures can provide a cushion, but without reforms, exporters will remain perpetually vulnerable.

Niti Aayog CEO flags India’s trade imbalance — ‘we trade in stuff world doesn’t require in large quantities’

According to the Niti Aayog quarter trade watch report launched Monday, India’s total trade in FY 2025 was at US$1.73 trillion—exports at US$823 billion & imports US$908 billion.

Army chief’s big warning to Pakistan: Stop sponsoring terrorism if you want to exist geographically

Amid continued concerns over cross-border terrorism, General Upendra Dwivedi further warned the neighbour that India will not show restraint if there is an Op Sindoor 2.0.

How Pakistan thinks: Army for hire, ideology of convenience

Pakistan’s army has been a rentier force available to a reasonable bidder. It has never come to the aid of any Muslims including Palestinians or the Gazans, except making noises here and there.