scorecardresearch
Add as a preferred source on Google
Wednesday, December 10, 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

How China reads US National Security Strategy—a return of America First in new language

Across the varied reading of the NSS in Chinese media, one thread recurs: The more Trump leans toward isolationism, the more volatile the global order is likely to become.

Niti Aayog CEO has a message for power stakeholders. Buckle up for surge to feed EVs, data centres

Clean energy is “no longer the sideshow, it is the show”, BVR Subrahmanyam told the Odisha summit, warning India to lead the global shift or risk others’ tech dominance.

Dubai Tejas crash revives focus on advanced, fully automated safety systems

Dubai airshow crash & pilot death have rekindled concerns over pilot safety, and need for smarter automated systems that can step in when G-forces, temporary loss of consciousness hit the pilot.

Asim Munir & Pakistan’s Failed Marshal Doctrine

None of Pakistan’s PMs has lasted 5 years. That the current PM has given Asim Munir 5 years shows that of all military dictatorships history has seen, Pakistan’s is most creative.