Search For "fda"
Glenmark Pharmaceuticals receives ANDA approval for Arformoterol Tartrate
Updated : 4 years, 9 months ago IST
Mumbai (Maharashtra) [India], June 23 (ANI/PRNewswire): Glenmark Pharmaceuticals Ltd (Glenmark) has received final approval by the United States Food & Drug Administration (U.S. FDA) for Arformoterol Tartrate Inhalation Solution, 15 mcg/2 mL, Unit-Dose Vials, the generic version of BROVA
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We respect US FDA decision, but it won't impact India's vaccine plan: Cent
Updated : 4 years, 9 months ago IST
New Delhi [India], June 11 (ANI): Reacting to the United States Food and Drug Administration (FDA)'s rejection of Bharat Biotech's Covaxin jab for emergency use authorization, the Union Health Ministry on Friday said that it respects the decision taken by the authority but it will not hav
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Third member of US FDA advisory panel resigns over Alzheimer's drug approv
Updated : 4 years, 9 months ago IST
Washington [US], June 11 (ANI): A third member of the US Food and Drug Administration (FDA) expert advisory panel resigned from the body after it approved a controversial Alzheimer's drug named Aduhelm recently.
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Bharat Biotech's US partner, Ocugen to apply for full approval for Covaxin
Updated : 4 years, 9 months ago IST
Pennsylvania [US], June 11 (ANI): Bharat Biotech's US partner Ocugen Inc said that the company will no longer pursue an Emergency Use Authorization (EUA) for COVAXIN and the US Food and Drug Administration (FDA) has recommended that the company go for the Biologics Licence Application (BL
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US FDA okays first new Alzheimer's drug in nearly 2 decades
Updated : 4 years, 9 months ago IST
Washington [US], June 8 (ANI): The United States Food and Drug Administration (FDA) has approved a new drug for Alzheimer's, the first new medicine against the disease in almost two decades.
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Glenmark Pharmaceuticals receives ANDA approval for Theophylline Extended-
Updated : 4 years, 9 months ago IST
Mumbai (Maharashtra) [India], June 4 (ANI/PRNewswire): Glenmark Pharmaceuticals Ltd (Glenmark) has received final approval by the United States Food & Drug Administration (U.S. FDA) for Theophylline Extended-release Tablets, 300 mg and 450 mg, bioequivalent and therapeutically equivalent
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US students who took India's Covaxin, Russia's Sputnik V, asked to get re-
Updated : 4 years, 9 months ago IST
Washington [US], June 4 (ANI): Since March, over 400 US colleges and universities have announced students get Covid-19 vaccinations, ahead of the Autumn semester but those who have been inoculated with India's indigenous Covaxin or the Russian-made Sputnik V are being asked to re-vaccinate a
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Glenmark Pharmaceuticals launches Rufinamide Tablets USP, 200 mg and 400 m
Updated : 4 years, 9 months ago IST
Mumbai (Maharashtra) [India], June 1 (ANI/PRNewswire): Glenmark Pharmaceuticals Limited (Glenmark) has launched Rufinamide Tablets USP, 200 mg and 400 mg, a therapeutic equivalent of Banzel® Tablets, 200 mg and 400 mg of Eisai, Inc.
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As pressure mounts on China over COVID-19 origins, ex-FDA chief says 'lab
Updated : 4 years, 9 months ago IST
Washington [US], May 31 (ANI): Amid mounting concerns regarding a renewed probe of the origins of COVID-19 in China, former US Food and Drug Administration (FDA) Commissioner Scott Gottlieb said that accidental lab leaks 'happen all the time' and there have been six last known outbreaks of S
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84-yr-old Haryana man, first in India to get antibody cocktail against Cov
Updated : 4 years, 10 months ago IST
Gurugram (Haryana) [India], May 26 (ANI): An 84-year-old man from Haryana has become the first person in India to be administered the Covid drug cocktail, which came into limelight after it was administered to former US President Donald Trump when he tested positive for the virus last yea
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Moderna says its COVID-19 vaccine 100 per cent effective in 12-17 age grou
Updated : 4 years, 10 months ago IST
Washington [US], May 25 (ANI): Moderna on Tuesday announced that various studies have shown its COVID-19 vaccine was 100 per cent effective at preventing infection in adolescents aged 12 to 17 and it planned on submitting the findings to global regulators in days.
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Evidence of COVID-19 originating from Chinese lab continues to grow: Forme
Updated : 4 years, 10 months ago IST
Washington [China], May 25 (ANI): The former head of the US Food and Drug Administration (FDA) on Monday said that circumstantial evidence of COVID-19 originating in a lab in China's Wuhan continues to grow as researchers are yet to prove that the virus jumped from an animal to humans, The H
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