Us Fda
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USFDA approves first vaccine to prevent disease caused by chikungunya virus
World | November 10, 2023 13:36 ISTChikungunya 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.
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Study identifies possible Covid drugs
Science | April 03, 2021 14:55 ISTA 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.
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Zydus Cadila gets USFDA nod for thyroid drug
World | January 23, 2021 12:08 ISTDrug firm Zydus Cadila has received final approval from the US health regulator to market Liothyronine Sodium tablets that are used to treat underactive thyroid.
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Glenmark Pharma gets tentative nod from USFDA for anticoagulant drug
World | December 21, 2020 11:56 ISTDrug major Glenmark Pharma on Monday said it has received tentative approval from the US health regulator for anticoagulant Dabigatran Etexilate capsules.
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FDA to quickly authorize second Covid-19 vaccine after panel favours Moderna's emergency approval
World | December 18, 2020 8:43 ISTThe 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.
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Aurobindo Pharma arm's New Jersey unit gets warning letter from USFDA
India | October 22, 2020 11:05 ISTDrug 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.
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Alembic Pharma gets USFDA nod for cholesterol lowering drug
Business | October 21, 2020 12:09 ISTDrug 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.
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Zydus Cadila gets tentative USFDA nod to market anti-cancer drug
Business | September 24, 2020 11:02 ISTZydus 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.
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Simple saliva test cleared by USFDA for early COVID-19 detection: Know what is it and how it is done
Health | August 16, 2020 14:24 ISTUSFDA 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.
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USFDA clears simple saliva test for faster detection of COVID-19
World | August 16, 2020 14:05 ISTThe 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.
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USFDA accepts proposed biosimilar application by Mylan, Biocon for review
Business | March 09, 2020 12:51 ISTThe 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.
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Unichem shares fall after USFDA observation, company says will form corrective plan soon
Business | August 26, 2019 11:53 ISTDrug firm Unichem Laboratories on Monday said the US health regulator has issued one observation after the inspection of its formulations facility at Ghaziabad.
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USFDA found different dietary, medicinal claims on Patanjali's sharbat bottles
India | July 21, 2019 15:34 ISTIf 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.
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Glenmark Pharma receives USFDA approval for Xylocaine skin ointment
Lifestyle | September 12, 2016 13:32 ISTGlenmark 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
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US food regulator okays Maggi noodles for consumption
India | August 12, 2015 12:10 ISTNew 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
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US FDA forfeits Ranbaxy's exclusivity for stomach drugs
January 27, 2015 16:12 ISTNew 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
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USFDA slaps import alert on Ipca Lab Ratlam facility; stock tanks
January 23, 2015 16:08 ISTNew 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
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USFDA finalizes menu and vending machine calorie labeling rule
December 17, 2014 13:22 ISTWashington: 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
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USFDA bans imports from Sun Pharma's Gujarat unit
March 13, 2014 18:22 ISTMumbai: 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
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Affordable drugs don't mean spurious: Azad tells US
India | February 10, 2014 20:18 ISTNew 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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