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Tag: usfda

You Searched For "usfda"
Abbott to release some nutrition products halted after baby formula recall

Abbott to release some nutrition products halted after baby formula recall

Ruchika Sharma1 May 2022 10:45 AM IST
The nutrition formulas Abbott is releasing include Calcilo XD, Cyclinex-1 and 2 and ProViMin, as well as Similac PM 60/40, the product lots being...
Bristol Myers Squibb gets USFDA nod for obstructive hypertrophic cardiomyopathy drug Camzyos

Bristol Myers Squibb gets USFDA nod for obstructive hypertrophic cardiomyopathy drug Camzyos

Ruchika Sharma1 May 2022 10:30 AM IST
Princeton: Bristol Myers Squibb has announced that the U.S. Food and Drug Administration (USFDA) has approved Camzyos (mavacamten, 2.5 mg, 5...
Moderna seeks USFDA emergency use nod for COVID vaccine in children younger than 6

Moderna seeks USFDA emergency use nod for COVID vaccine in children younger than 6

Ruchika Sharma29 April 2022 11:59 AM IST
Moderna is also currently studying booster doses for all pediatric cohorts.
Pfizer seeks USFDA emergency use nod for COVID booster in children aged 5 through 11 years

Pfizer seeks USFDA emergency use nod for COVID booster in children aged 5 through 11 years

Ruchika Sharma28 April 2022 3:22 PM IST
New York: Pfizer Inc. and BioNTech SE have submitted an application to the U.S. Food and Drug Administration (USFDA) for Emergency Use Authorization...
Gufic Biosciences bags CDSCO approval to manufacture drug for severe fungal infections

Gufic Biosciences bags CDSCO approval to manufacture drug for severe fungal infections

Ruchika Sharma27 April 2022 12:52 PM IST
Isavuconazole for Injection 200 mg/vial is indicated for the treatment of patients who are 18 years of age and above.
Gilead Sciences Remdesivir gets USFDA nod for young children

Gilead Sciences Remdesivir gets USFDA nod for young children

Ruchika Sharma26 April 2022 3:06 PM IST
Under the expanded indication, a three-day Remdesivir treatment regimen is recommended to help prevent hospitalization in non-hospitalized COVID-19...
Aleor Derma gets USFDA nod for Clobetasol Propionate Foam

Aleor Derma gets USFDA nod for Clobetasol Propionate Foam

Ruchika Sharma25 April 2022 3:02 PM IST
Clobetasol Propionate foam is a corticosteroid indicated for treatment of moderate to severe plaque psoriasis of the scalp.
Sun Pharma, Aurobindo, Jubilant recall products in US

Sun Pharma, Aurobindo, Jubilant recall products in US

Ruchika Sharma25 April 2022 11:48 AM IST
The USFDA has classified the recalls as Class III, which is initiated in a " situation in which use of, or exposure to, a violative product is not...
Dr Reddys unveils Posaconazole delayed-release tablets in US

Dr Reddys unveils Posaconazole delayed-release tablets in US

Ruchika Sharma22 April 2022 12:02 PM IST
Hyderabad: Drugmaker, Dr Reddy's Laboratories Ltd. has announced the launch of Posaconazole Delayed-Release Tablets, 100 mg in the...
Moderna to file for COVID vaccine EUA for children under 6

Moderna to file for COVID vaccine EUA for children under 6

Ruchika Sharma22 April 2022 10:53 AM IST
New Delhi: Moderna plans to submit an application to the US health regulator for emergency use authorization (EUA) of its Covid-19 vaccine among kids...
Alembic Pharma gets USFDA nod for heart failure drug lvabradine

Alembic Pharma gets USFDA nod for heart failure drug lvabradine

Ruchika Sharma20 April 2022 2:30 PM IST
Vadodara: Alembic Pharmaceuticals Limited today announced that the company has received tentative approval from the US Food & Drug...
Kite gets USFDA nod for new CAR T-cell therapy site in Maryland

Kite gets USFDA nod for new CAR T-cell therapy site in Maryland

Ruchika Sharma20 April 2022 1:12 PM IST
Santa Monica: Kite, a Gilead Company has announced the U.S. Food and Drug Administration (USFDA) has approved commercial production at the company's...
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