Search For "fda"
Glenmark Pharmaceuticals receives ANDA approval for Icatibant Injection, 3
Updated : 4 years, 10 months ago IST
Mumbai (Maharashtra) [India], May 24 (ANI/PRNewswire): Glenmark Pharmaceuticals Limited (Glenmark) has received final approval by the United States Food & Drug Administration (U.S. FDA) for Icatibant Injection, 30 mg/3 mL (10 mg/mL) Single-Dose Prefilled Syringe, the generic version of F
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US FDA approves emergency use of Pfizer-BioNTech vaccine for children in 1
Updated : 4 years, 10 months ago IST
Washington [US], May 11 (ANI): The US Food and Drug Administration (FDA) on Monday (local time) authorised the emergency use of the Pfizer-BioNTech COVID-19 vaccine to children in the age group of 12-15 years.
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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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US lifts pause on use of Johnson & Johnson COVID-19 vaccine
Updated : 4 years, 11 months ago IST
Washington [US], April 24 (ANI): The US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) have determined that the recommended pause regarding the use of Johnson & Johnson COVID-19 Vaccine in the US should be lifted and use of the vaccine should
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Johnson & Johnson trails shows vaccine effective even against variants
Updated : 4 years, 11 months ago IST
New Jersey [US], April 22 (ANI): Johnson & Johnson's single-shot coronavirus vaccine protected against symptomatic and asymptomatic infection, and prevented hospitalization and death in all participants 28 days after vaccination, according to new clinical trial results published on Wedne
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11 killed in oxygen tanker leak incident in Maharashtra's Nashik
Updated : 4 years, 11 months ago IST
Nashik (Maharashtra) [India], April 21 (ANI): Eleven people were killed in an oxygen tanker leak incident at Dr Zakir Hussain Hospital in Maharashtra's Nashik district, said Food and Drug Administration (FDA) Minister Rajendra Shingane on Wednesday.
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Mumbai Police, FDA recover 2,200 vials of Remdesivir in raids
Updated : 4 years, 11 months ago IST
Mumbai (Maharashtra) [India], April 20 (ANI): In a joint operation, Mumbai Police and Food and Drugs Administration (FDA) teams raided two locations on Monday and recovered 2,200 vials of Remdesivir.
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US revokes authorisation of one of Eli Lilly's COVID-19 monoclonal antibod
Updated : 4 years, 11 months ago IST
Washington [US], April 17 (ANI): The US Food and Drug Administration (FDA) said on Friday that it has revoked it emergency authorisation of Eli Lilly's COVID-19 monoclonal antibody treatment bamlanivimab when used on its own.
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Centre issues regulatory pathways for foreign-produced COVID-19 vaccines
Updated : 4 years, 11 months ago IST
New Delhi [India], April 15 (ANI): In view of the rapid surge in coronavirus cases in India, the Central government approved a significant streamlining and fast-tracking of the regulatory system for COVID-19 vaccines approved for restricted use by US FDA, EMA, UK MHRA, PMDA Japan or which ar
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Health Ministry issues regulatory pathways for foreign-produced COVID-19 v
Updated : 4 years, 11 months ago IST
New Delhi [India], April 15 (ANI): The Central Government on Thursday issued the regulatory pathway in India for COVID-19 vaccines approved for restricted use by US FDA, EMA, UK MHRA, PMDA Japan or which are listed in WHO Emergency Use Listing (EUL), said the Union Health Ministry.
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South Africa suspends use of Johnson & Johnson COVID-19 vaccine
Updated : 4 years, 11 months ago IST
Johannesburg [South Africa], April 14 (ANI): South African Health Minister Zweli Mkhize on Tuesday said that the country will be suspending the use of the Johnson & Johnson COVID-19 vaccine after health concerns raised by the US Food and Drug Administration (FDA).
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FDA recommends pause in use of Johnson & Johnson COVID-19 vaccine
Updated : 4 years, 11 months ago IST
Washington [US], April 13 (ANI): The US Centers of Disease Control and Prevention (CDC) and the US Food and Drug Administration (FDA) have recommended "pause" in the use of Johnson and Johnson COVID-19 vaccine "out of an abundance of caution" over six reported cases in the US of a "rare and
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