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Friday, November 1, 2024
TopicUSFDA

Topic: USFDA

In a 1st for US, its FDA approves at-home use of nasal flu vaccine; India’s version yet to gain traction

US's FluMist can now be administered by a healthcare provider or by recipient or caregiver aged 18 or above. India's Nasovac S4 faces hurdles like cost, availability & low acceptance.

Import alerts, warning letters, drug recalls — why ‘pharmacy to the world’ is facing US FDA heat

New Delhi: On 18 April, Mumbai-headquartered Marksans Pharma, a drugmaker that supplies generic drugs in over 50 countries around the world, received form 483,...

Using smartwatch to monitor blood glucose level? US FDA strongly advises against it

US regulator says devices that claim to monitor blood glucose levels in real time without piercing skin may show inaccurate & misleading results and pose risks for people with diabetes.

US FDA approves ‘Xolair’ injection — all about the drug that can help treat severe food allergies

The drug, which blocks allergic reactions to more than one type of food, is the first FDA-approved medication to reduce risk of anaphylaxis from accidental exposure to multiple foods.

‘Genetic scissors’ — India using same tech to find sickle cell cure as gene therapy approved by US FDA

FDA-approved Casgevy & Lyfgenia made from patients’ blood stem cells which are modified and given back as single-dose infusion. India ‘in preclinical stage’ of trial of similar therapy.

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.

On Camera

16th BRICS Summit was about building dollar-free world order. India can use it to expand trade

For New Delhi, a USD-free system is not an immediate priority nor an existential necessity to unconditionally support the China-Russia agenda.

Watch CutTheClutter: Flattening INR-USD rate, and debate on pros and cons of a ‘strong’ rupee

In Episode 1544 of CutTheClutter, Editor-in-Chief Shekhar Gupta looks at some top economists pointing to the pitfalls of ‘currency nationalism’ with data from 1991 to 2004.

All about Major Bob Khathing, whose daring expedition & diplomatic parleys secured Tawang for India

The decorated Naga officer from Manipur also served as envoy to Myanmar & Nagaland chief secy. Defence Minister Rajnath Singh inaugurated a museum dedicated to the Tawang hero Thursday.

From 2004 to 2024, bad news has come wrapped as good news for Congress

Congress is silently acknowledging it over-read verdict of last general election. You can see it in easy concession to SP. It will likely be more reasonable in Maharashtra & Jharkhand.