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Wednesday, November 19, 2025
TopicUSFDA

Topic: USFDA

Paracetamol linked to autism? As Trump warns pregnant women, here’s what science says

President Trump claimed taking Tylenol, simply known as paracetamol, ‘is no good’ & that pregnant women should ‘fight like hell’ to only take it in cases of extreme fever.

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—McKinsey 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.

On Camera

India has to move on now. Engage with ‘Nooton Bangladesh’

Former Bangladesh Prime Minister Sheikh Hasina has, in a sense, tasted her own medicine. The International Crimes Tribunal, the special court she instituted for...

The day Dharmendra ‘died’

At Charcha 2025: Local entrepreneurship, not just big IT, will drive next wave of distributed AI work

While global corporations setting up GCCs in India continue to express confidence in availability of skilled AI engineers, the panel argued that India’s real challenge lies elsewhere.

Drone manufacturer ideaForge wins orders worth over Rs 100 crore from Army

ideaForge has formed a joint venture to manufacture and market UAVs in the US. Its Q6 UAV is now included in NATO and allied procurement systems.

INDIA has a Congress-sized hole. And the fix begins with a little humility

Without a Congress revival, there can be no challenge to the BJP pan-nationally. Modi’s party is growing, and almost entirely at the cost of the Congress.