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US FDA flags manufacturing lapses at Dabur's Silvassa plant; company issues clarification

India | Jun 02, 2026, 07:55 PM IST

US FDA has flagged multiple deficiencies at Dabur India's manufacturing facility in Dadra and Nagar Haveli, including data integrity, contamination and maintenance concerns. Meanwhile, the Indian multinational consumer goods company has responded to the US FDA's allegations.

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USFDA approves first vaccine to prevent disease caused by chikungunya virus

World | Nov 10, 2023, 01:36 PM IST

Chikungunya virus vaccine: Transmission of chikungunya virus to newborn babies from pregnant individuals with viremia (virus present in the blood) at delivery has been reported and can cause severe, potentially fatal chikungunya virus disease in newborns.

Study identifies possible Covid drugs

Science | Apr 03, 2021, 02:55 PM IST

A team of researchers has identified nine potential new Covid-19 treatments, including three, that were already approved by the US Food and Drug Administration (FDA) for treating other diseases.

Zydus Cadila gets USFDA nod for thyroid drug

World | Jan 23, 2021, 12:08 PM IST

Drug firm Zydus Cadila has received final approval from the US health regulator to market Liothyronine Sodium tablets that are used to treat underactive thyroid.

Glenmark Pharma gets tentative nod from USFDA for anticoagulant drug

World | Dec 21, 2020, 11:56 AM IST

Drug major Glenmark Pharma on Monday said it has received tentative approval from the US health regulator for anticoagulant Dabigatran Etexilate capsules.

A second COVID-19 vaccine moved closer to joining the US fight against the pandemic on Thursday as g

FDA to quickly authorize second Covid-19 vaccine after panel favours Moderna's emergency approval

World | Dec 18, 2020, 08:43 AM IST

The head of the Food and Drug Administration said late Thursday that his agency will move to quickly authorize the second COVID-19 vaccine to fight the pandemic, hours after the shot won the key endorsement of a government advisory panel.

Aurobindo Pharma arm's New Jersey unit gets warning letter from USFDA

India | Oct 22, 2020, 11:05 AM IST

Drug firm Aurobindo Pharma Thursday said its step-down subsidiary has received a warning letter from the US health regulator for its unit in New Jersey, US.

Alembic Pharma gets USFDA nod for cholesterol lowering drug

Business | Oct 21, 2020, 12:09 PM IST

Drug firm Alembic Pharma on Wednesday said it has received approval from the US health regulator for Fenofibrate capsules, which reduces cholesterol and triglycerides in blood.

Zydus Cadila gets tentative USFDA nod to market anti-cancer drug

Business | Sep 24, 2020, 11:02 AM IST

Zydus Cadila has received tentative approval from the US Food and Drug Administration (USFDA) to market Palbociclib Capsules in the strengths of 75 mg, 100 mg, and 125 mg, Zydus Cadila, part of the Cadila Healthcare group, said in a regulatory filing.

USFDA clears simple saliva test for faster detection of COVID-19: Know what is it and how it is done

Simple saliva test cleared by USFDA for early COVID-19 detection: Know what is it and how it is done

Health | Aug 16, 2020, 02:24 PM IST

USFDA has previously authorized four other tests that use saliva for sampling, but these yielded varying results. Authorization of the new test occurs amid ongoing disarray over COVID-19 testing.

USFDA clears simple saliva test for faster detection of COVID-19

World | Aug 16, 2020, 02:05 PM IST

The US health watchdog has authorised the emergency use of a new and expensive saliva based laboratory diagnostic test for COVID-19 that could be a game changer in the diagnosis of the infection as it will enable rapid testing amongst more people easily.

USFDA accepts proposed biosimilar application by Mylan, Biocon for review

Business | Mar 09, 2020, 12:51 PM IST

The US Food and Drug Administration (USFDA) has accepted biologics license application by Mylan and Biocon for proposed biosimilar to Bevacizumab for review, according to a regulatory filing.

Unichem shares fall after USFDA observation, company says will form corrective plan soon

Business | Aug 26, 2019, 11:53 AM IST

Drug firm Unichem Laboratories on Monday said the US health regulator has issued one observation after the inspection of its formulations facility at Ghaziabad.

USFDA found different dietary, medicinal claims on Patanjali's sharbat bottles

India | Jul 21, 2019, 03:34 PM IST

If the company is found to be selling a misbranded product in the US, the USFDA can issue a warning letter to stop that product's import altogether, seize the whole batch of that product, get an injunction from a federal court against the company, and even start criminal prosecution that can lead to fines up to USD 500,000 and imprisonment of company officials for up to three years.