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Monday, August 25, 2025
TopicUSFDA

Topic: USFDA

Indian doctors more confident about oestrogen therapy for menopause as USFDA may scrap black box warning

USFDA, in a discussion telecast publicly last month, said local oestrogen therapy, such as vaginal cream, is safe & the risks of hormone replacement therapy were overstated.

Top pharma alliance refutes ‘ill-researched’ US study linking Indian generics to higher adverse events

Indian Pharmaceutical Alliance says the study relies on FDA Adverse Event Reporting System data, which captures link between drugs & adverse events, but does not prove causation.

Indian pharmas improved USFDA compliance, but cases of contamination grew 2014-2024—IPA report

The report, released at Global Pharmaceutical Quality Summit in Mumbai, draws comparison of incidences of ‘official action indicated' after USFDA inspections a decade apart.

Govt says no plan to ban heartburn drug ranitidine, carcinogenic impurities within safe limits

In 2019, evidence showed that an impurity in drug degrades over time to form probable carcinogenic compound. Ranitidine is sold as heartburn medicine under names Rantac, Aciloc & Zinetac.

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’.

On Camera

Indians should adopt stray dogs. It’s what Hindu value system teaches

Compassion and cohabitation with animals are ingrained in the Indian value system. A humane solution must be found for the rising conflict between man and free-range animals.

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.

Army ramps up two-front readiness, 5 Bhairav Commando units ready for frontline deployment

Three battalions are being deployed along northern frontier with China and Pakistan, one in the northeast and another on western front, ThePrint has learnt.

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.