Search For "fda"
FDA denies authorization to market JUUL e-cigarettes over safety concerns
Updated : 3 years, 9 months ago IST
Maryland [US], June 24 (ANI): Citing safety concerns, the US Food and Drug Administration (FDA) issued marketing denial orders (MDOs) to JUUL Labs Inc. for their e-cigarettes among others which are currently marketed in the United States.
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US: CDC recommends COVID-19 vaccines for children under five
Updated : 3 years, 9 months ago IST
Washington [US], June 19 (ANI): The US regulators, the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) on Saturday authorized and recommended the first COVID-19 vaccines for kids under the age of five.
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US approves Pfizer, Moderna Covid-19 vaccines for youngest children
Updated : 3 years, 9 months ago IST
Washington [US], June 17 (ANI): The US Food and Drug Administration (FDA) authorized emergency use of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to include use in children down to 6 months of age.
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First patient enrolled in SELUTION SLR IDE BTK Study
Updated : 3 years, 9 months ago IST
Leipzig [Germany], June 8 (ANI/PRNewswire): The first patient has been enrolled in the FDA IDE BTK (Below-the-Knee) SELUTION4BTK clinical trial involving SELUTION SLR™, MedAlliance's novel sirolimus-eluting balloon, just one week after receiving IDE approval.
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Hepatitis A outbreak in US, Canada sparked by contaminated organic strawbe
Updated : 3 years, 9 months ago IST
Washington [US], May 30 (ANI): The Food and Drug Administration (FDA) urged customers to throw out any uneaten batches of organic strawberries as they may be the cause of the multistate outbreak of hepatitis A infections in the US and Canada.
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FDA removes hold on clinical trial for phase 2,3 for COVAXIN-BBV152 says
Updated : 3 years, 10 months ago IST
Malvern (Pennsylvania) [US], May 23 (ANI): Biotechnology company Ocugen on Monday announced that the US Food and Drug Administration (FDA) lifted the clinical hold on the Company's Phase 2, 3 clinical trials for COVAXIN™ (BBV152).
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Glenmark Pharmaceuticals receives sANDA approval for Abiraterone Acetate T
Updated : 3 years, 10 months ago IST
Mumbai (Maharashtra) [India], May 20 (ANI/PRNewswire): Glenmark Pharmaceuticals Inc, USA (Glenmark) has received final approval by the United States Food & Drug Administration (US FDA) for Abiraterone Acetate Tablets USP, 500 mg, the generic version of Zytiga®1 Tablets, 500 mg, of J
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NeoImmuneTech obtains approval for phase 2 trial of brain tumor treatment
Updated : 3 years, 10 months ago IST
Seoul [South Korea], May 12 (ANI/Global Economic): NeoImmuneTech said on the 11th that it has obtained the approval for a phase 2 clinical trial plan that concomitant administration of US Merck's immune checkpoint inhibitor Keytruda and its T-cell amplifier NT-I7 to patients with glioblastom
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Glenmark Pharmaceuticals receives tentative ANDA approval for Calcipotrien
Updated : 3 years, 10 months ago IST
Mumbai (Maharashtra) [India], May 9 (ANI/PRNewswire): Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted tentative approval by the United States Food & Drug Administration (U.S. FDA) for Calcipotriene and Betamethasone Dipropionate Foam, 0.005 per cent|0.064 per cent, the gen
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US FDA limits use of Johnson & Johnson COVID-19 vaccine over blood clo
Updated : 3 years, 10 months ago IST
Washington [US], May 6 (ANI): The US Food and Drug Administration (FDA) on Thursday said that the Johnson & Johnson vaccine that has been administered to more than 18 million Americans can potentially cause "life-threatening blood clots", and thereby warranted "limiting the authorized us
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FDA approves Direct Biologics to proceed with a Landmark Phase 3 Acute Res
Updated : 3 years, 11 months ago IST
Austin (Texas) [US], April 22 (ANI/PRNewswire): Direct Biologics, a regenerative biotechnology company with a groundbreaking extracellular vesicle (EV) platform technology, announced today that the FDA has approved the company to proceed with its Phase 3 clinical trial using its investigatio
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FDA authorizes first-ever breathing test for detecting COVID-19 infection
Updated : 3 years, 11 months ago IST
Washington [US], April 16 (ANI): The Food and Drug Administration (FDA) authorized the first test, InspectIR COVID-19 Breathalyzer, to detect COVID-19 through the breath for emergency use.
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