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USFDA

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

by Shawn Butlere
Import alerts, warning letters, drug recalls — why ‘pharmacy to the world’ is facing US FDA heat – ThePrint – Select

Marksans, whose product portfolio includes therapeutic segments of cardiovascular, central nervous system, antidiabetic, pain management, gastroenterology and anti-allergy drugs and whose market capitalisation stood at Rs 5,299.75 crore in August last …

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Categories Health

US FDA advises against using smartwatch to monitor blood glucose level

by Shawn Butlere
US FDA advises against using smartwatch to monitor blood glucose level

New Delhi: Wearable devices such as smartwatches and smart rings that claim to measure blood glucose levels in real-time without piercing the skin may seem convenient for people with diabetes. …

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Categories Health

US FDA approves ‘Xolair’, drug that can treat severe food allergies

by Shawn Butlere
US FDA approves ‘Xolair’, drug that can treat severe food allergies

New Delhi: The US Food and Drug Administration (FDA) has approved Omalizumab, which is sold under the brand name Xolair, to treat severe food allergies — making it the first …

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Categories Health

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

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

New Delhi: The US Food and Drug Administration (USFDA) last week approved two breakthrough gene therapies — Casgevy by Vertex Pharmaceuticals and CRISPR Therapeutics, and Lyfgenia by Bluebird Bio — for sickle …

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Categories Health

World’s 1st vaccine against chikungunya primed for launch in India, says French drugmaker Valneva

by Shawn Butlere
World’s 1st vaccine against chikungunya primed for launch in India, says French drugmaker Valneva

New Delhi: French biotech company Valneva, whose vaccine against mosquito-borne illness chikungunya received approval from the US Food and Drug Administration (USFDA) last week — becoming the first licensed vaccine …

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Categories Health

Cure for sickle cell disease on the horizon? US drug regulator is reviewing 2 new gene therapies

by Shawn Butlere
Cure for sickle cell disease on the horizon? US drug regulator is reviewing 2 new gene therapies

Bengaluru: The deadly sickle cell disease (SCD), which causes blood cells to deform into a sickle shape, could potentially have two cures by the end of the year. A new …

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Categories Health

Drug companies on high alert amidst increased scrutiny on USFDA

by Craig Fedirighi
Drug companies on high alert amidst increased scrutiny on USFDA

MUMBAI: A US congressional panel has expressed concerns about the lack of effective action taken by the national drug regulator Food and Drug Administration (FDA) regarding quality lapses in manufacturing …

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Categories Business

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