Search For "authorization"
DCGI approves Hetero's Tocilizumab for treatment of COVID-19 in hospitalis
Updated : 4 years, 6 months ago IST
Hyderabad (Telangana) [India], September 6 (ANI): Hetero announced on Monday that the Drug Controller General of India (DCGI) has approved Emergency Use Authorization (EUA) for its generic version of Tocilizumab in India for the treatment of COVID-19 in hospitalised adults.
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COVID-19: Brazil bans use of Chinese vaccines made at unauthorised plant
Updated : 4 years, 6 months ago IST
Brasilia [Brazil], September 5 (ANI): Brazil has banned the distribution of millions of Chinese Sinovac COVID-19 vaccines as the plant in which they were made is not authorised by the Latin American country's health regulator.
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Enzene Biosciences Ltd. obtains a Marketing Authorization for its Denosuma
Updated : 4 years, 6 months ago IST
Pune (Maharashtra) [India], August 27 (ANI/PRNewswire): Enzene Biosciences Ltd. "Enzene" announces a successful Marketing Authorization (MA) from the Drug Controller General of India (DCGI) for its third biosimilar drug 'Denosumab', indicated for the treatment of osteoporosis in adults.
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Philippines approves Russia's Sputnik Light vaccine
Updated : 4 years, 6 months ago IST
Moscow [Russia], August 23 (ANI): The Philippines' Food and Drug Administration approved the single-component Sputnik Light coronavirus vaccine under the emergency use authorization procedure on Monday, the Russian Direct Investment Fund said.
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Enzene Biosciences Ltd. obtains Marketing Authorization for its Romiplosti
Updated : 4 years, 6 months ago IST
Pune (Maharashtra) [India], August 20 (ANI/PRNewswire): Enzene Biosciences Ltd. "Enzene" announces a successful Marketing Authorization (MA) from the Drug Controller General of India (DCGI) for its second biosimilar drug "Romiplostim", indicated for the treatment of chronic Immune Thrombocyt
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Johnson & Johnson's single-dose COVID-19 vaccine gets emergency use ap
Updated : 4 years, 7 months ago IST
New Delhi [India], August 7 (ANI): US pharma giant Johnson and Johnson's single-dose COVID-19 vaccine Janssen has received approval for Emergency Use Authorization (EUA) in India, informed Union Health Minister Mansukh Mandaviya on Saturday.
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Johnson and Johnson applies for Emergency Use Authorization of its single-
Updated : 4 years, 7 months ago IST
New Delhi [India], August 6 (ANI): US pharma giant Johnson and Johnson on Friday said it has applied for Emergency Use Authorization (EUA) of its single-dose COVID-19 vaccine Janssen to the Government of India.
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Drug regulator urges Pfizer to apply for COVID-19 vaccine launch in India
Updated : 4 years, 8 months ago IST
New Delhi [India], July 6 (ANI): The Indian drug regulator has urged Pfizer twice in writing to apply for emergency use authorization for its COVID-19 vaccine so that the application is processed well in time but Pfizer has not applied for the license yet, said sources on Tuesday.
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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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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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Schools in US under pressure to reopen for in-person learning
Updated : 4 years, 10 months ago IST
Washington [US] May 17, (ANI): Schools in United States are under pressure to open in-person learning given the authorization of a vaccine for children ages 12 to 15 and new federal guidance that vaccinated people do not need to wear face masks indoors or outdoors.
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Pfizer, BioNTech seek full approval of COVID-19 vaccine across US
Updated : 4 years, 10 months ago IST
Washington [US], May 7 (ANI): Pharmaceutical giants Pfizer and BioNTech on Friday said that they have started the process for getting the US Food and Drug Administration (FDA) complete authorisation of its COVID-19 vaccine after having emergency use authorization for almost five months.
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