usfda

US FDA accepts Amneal’s Biologics License Application for Bevacizumab

Amneal Pharmaceuticals announced the US Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for…

3 years ago

Zydus Cadila gets tentative US FDA approval for Brivaracetam tablets

Zydus Cadila has received tentative approval from the USFDA to market Brivaracetam Tablets, in the strengths of 10 mg, 25…

3 years ago

USFDA denies Bharat Bhiotech’s partner emergency approval for Covaxin

In a recent development, the US Food and Drug Administration there has "recommended" Ocugen Inc, the US partner of the…

3 years ago

Lupin gets USFDA nod to market generic HIV drug

Lupin has received a nod from the US health regulator to market generic emtricitabine and tenofovir disoproxil fumarate tablets used…

3 years ago

USFDA nod to Zydus for production of Fluphenazine Hydrochloride

Zydus Cadila has received final approval from the USFDA to market Fluphenazine Hydrochloride Tablets in the strengths of 1 mg,…

3 years ago

Glenmark gets US FDA nod for Icatibant injection, 30 mg/3 mL (10 mg/mL) single-dose prefilled syringe

Glenmark Pharmaceuticals has received final approval by the United States Food & Drug Administration (US FDA) for Icatibant Injection, 30…

3 years ago

Glenmark Pharma gets USFDA nod for cholesterol lowering drug

Glenmark Pharmaceuticals Friday said it has received final approval from the US health regulator for Ezetimibe and Simvastatin tablets, used…

3 years ago

USFDA approves Pfizer for use in 12-15 years old

The United States’ drug regulator on Monday expanded the emergency authorisation given to the Pfizer Covid vaccine for use in children as…

3 years ago

Pfizer and BioNTech Initiate Rolling Submission of Biologics License Application for U.S. FDA Approval of their COVID-19 Vaccine

Pfizer and BioNTech SE today announced the initiation of Biologics License Application (BLA) with the U.S. Food and Drug Administration…

4 years ago

US FDA to approve Pfizer among adolescents

The Food and Drug Administration (FDA) of U.S. is about to approve the use of two-dose Pfizer vaccine among children…

4 years ago