Search For "food and drug administration"
FDA issues first emergency use authorisation for COVID-19 pool testing
Updated : 5 years, 8 months ago IST
Washington D.C. [USA], July 19 (ANI): The US Food and Drug Administration (FDA) on Saturday (local time) issued an emergency use authorisation (EUA) to Quest Diagnostics that allows pool samples from up to four individuals to test for COVID-19.
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Indian pharma compliance standards improving, regulatory risks here to sta
Updated : 5 years, 8 months ago IST
Mumbai (Maharashtra) [India], July 7 (ANI): Indian pharmaceutical companies have built a strong abbreviated new drug application (ANDA) pipeline since FY12 through scaling-up of investments in R&D but this will increase the inspection intensity, India Ratings and Research (Ind-Ra) said o
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Mylan gets DCGI nod for remdesivir in India, to launch at Rs 4,800 per via
Updated : 5 years, 8 months ago IST
Bengaluru (Karnataka) [India], July 7 (ANI): Global pharmaceutical major Mylan has got approval for its remdesivir from the Drug Controller General of India (DCGI) and will launch a generic version of Gilead Sciences' COVID-19 anti-viral in the country at Rs 4,800 for 100 mg/vial.
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US approved 4 COVID-19 vaccine candidates for clinical trials - FDA Head
Updated : 5 years, 8 months ago IST
Washington [US], July 1 (Sputnik/ANI): The United States has approved four coronavirus vaccine candidates for clinical trials, Food and Drug Administration (FDA) head Stephen Hahn told reporters.
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US left with 63 million doses of anti-malarial drug after FDA revoked its
Updated : 5 years, 9 months ago IST
Washington D.C. [USA], June 19 (ANI): The US federal government is now left with 63 million doses of hydroxychloroquine sulfate (HCQ) in its stockpile after the Food and Drug Administration (FDA) earlier this week, revoked the permission for use of anti-malarial drug in treating COVID-19
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US FDA revokes emergency authorisation for HCQ championed by President Tru
Updated : 5 years, 9 months ago IST
Washington D.C. [US], June 15 (ANI): The US Food and Drug Administration (FDA) on Monday revoked the emergency use authorization for malaria drug hydroxychloroquine (HCQ) as a treatment for COVID-19, the use of which has been championed by President Donald Trump.
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Zydus signs licensing agreement with Gilead to manufacture and market Remd
Updated : 5 years, 9 months ago IST
Ahmedabad (Gujarat) [India], June 13 (ANI): Healthcare major Zydus Cadila has signed a non-exclusive licensing agreement with Gilead Sciences Inc for the manufacturing and distribution of Remdesivir, the investigational drug which has been issued an emergency use authorisation by the US Food
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With new approaches against Coronavirus, doctors express 'glimmers of hope
Updated : 5 years, 10 months ago IST
Washington D.C. [US], May 14 (ANI): Those on the frontline in the battle against coronavirus are expressing "glimmers of hope" as far as the treatment of COVID-19 patients is concerned.
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COVID-19: Cipla enters into licensing pact with Gilead to manufacture and
Updated : 5 years, 10 months ago IST
Mumbai (Maharashtra) [India], May 13 (ANI): Pharmaceutical major Cipla said on Wednesday it has signed a non-exclusive licensing agreement with Gilead Sciences Inc for manufacturing and distributing investigational medicine Remdesivir which has been issued an emergency use authorisation by t
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US approves antigen test to diagnose COVID-19
Updated : 5 years, 10 months ago IST
Washington (US), May 10 (ANI: The US Food and Drug Administration (FDA) has authorized the use of antigen test for the first time to detect and treat COVID-19 infection.
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Gilead's anti-viral remdesivir gets FDA emergency use authorisation for tr
Updated : 5 years, 10 months ago IST
California [USA], May 2 (ANI): US-based biopharmaceutical major Gilead Sciences said that the US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) for investigational anti-viral remdesivir to treat COVID-19.
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US FDA authorises emergency use of Remdesivir in coronavirus treatment
Updated : 5 years, 10 months ago IST
Washington D.C. [US], May 2 (Sputnik/ANI): The US Food and Drug Administration has authorized an emergency use of Remdesivir drug in coronavirus treatment, FDA head Stephen Hahn announced on Friday.
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