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Wednesday, October 29, 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—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.

On Camera

Takaichi channels Abe & wins over Trump

Trump calls Takaichi 'one of the greatest prime ministers' & offers her 'anything you want'.

Mumbai’s been driving India’s data centre market, but water shortage, power demand pose risks

According to a report by Macquarie, India’s data centre market is estimated to double by 2027. India currently has 1.4 gigawatts of operational data centre capacity.

Navy Chief calls for collective solutions to maritime challenges in ‘complex & dynamic’ Indo-Pacific

At 11th edition of Indo-Pacific Regional Dialogue in New Delhi, Navy Chief Admiral Dinesh K Tripathi said there are three major currents shaping this maritime 'dynaxity'.

Deepfake on duty: when I asked AI to read Op Sindoor citations

On 21 Oct, a buzz went up that the govt had released full list of gallantry award recipients along with Op Sindoor citations. I put an AI caddy on the job. It took me into a never-ending rabbit hole.