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.
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.
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.
Drug major Glenmark Pharma on Monday said it has received tentative approval from the US health regulator for anticoagulant Dabigatran Etexilate capsules.
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.
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.
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 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 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.
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.
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.
Drug firm Unichem Laboratories on Monday said the US health regulator has issued one observation after the inspection of its formulations facility at Ghaziabad.
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.
Glenmark Pharmaceuticals on Monday received final approval from the US health regulator USFDA for its generic version of AstraZeneca's Xylocaine ointment. The approval given by the US Food & Drug Administration (USFDA) to Glenmark Pharmaceuticals
New Delhi: As a ban continues in India on Nestle's Maggi noodles, the US health regulator USFDA has said its tests have found the lead level in the popular instant food within acceptable levels for
New Delhi: Drug major Ranbaxy said that the US health regulator has "determined" that the Indian drug manufacturer has forfeited its 180 days exclusivity for stomach and esophagus problems treatment tablets."We have now received a
New Delhi: The US health regulator has issued import alert on drugs produced at Ipca Laboratories Ratlam in Madhya Pradesh, following which the company has suspended shipment of active pharmaceutical ingredients to the American market."We
Washington: Don't want to be confronted with the number of calories in that margarita or craft beer? Then avoid the menu and order at the bar.New menu labeling rules from the Food and Drug Administration
Mumbai: The US Food and Drug Administration (US FDA) has banned imports from Indian generic drugmaker Sun Pharmaceutical Industries Ltd's plant at Karkhadi in the western state of Gujarat.The alert was issued by the US
New Delhi: Against the backdrop of US actions against Indian pharma exports, Health Minister Ghulam Nabi Azad today did some plainspeak with the head of American drug regulator, asserting that Indian drugs should not be
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