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Tag: usfda

You Searched For "usfda"
Lupin bags tentative USFDA nod for rare autoimmune disorder drug Amifampridine

Lupin launches generic equivalent of Northera capsules in US

Ruchika Sharma29 Sept 2021 1:00 PM IST
Mumbai: Global pharma major Lupin Limited has recently announced the launch of Droxidopa Capsules, 100 mg, 200 mg, and 300 mg, having received...
Pfizer to submit Covid-19 vaccine data for kids aged 5 to 11

Pfizer to submit Covid-19 vaccine data for kids aged 5 to 11

MD Bureau28 Sept 2021 11:00 AM IST
Washington: Pfizer is soon expected to submit data to the US Food and Drug Administration (FDA) regarding safety of its mRNA Covid vaccine for...
Biocon Biologics gets 6 USFDA observations for Malaysia facility

Biocon Biologics gets 6 USFDA observations for Malaysia facility

Ruchika Sharma27 Sept 2021 2:10 PM IST
Bangalore: Pharma major Biocon has recently announced that the US Food and Drug Administration (USFDA) has concluded an inspection with 6 observations...
Baxter launches cardiovascular medicine Norepinephrine in premix formulation in US

Baxter launches cardiovascular medicine Norepinephrine in premix formulation in US

Ruchika Sharma27 Sept 2021 9:00 AM IST
New Delhi: Baxter International Inc. has recently announced the U.S. Food and Drug Administration (USFDA) approval and commercial launch of premix...
Caplin Point CRO successfully completes USFDA audit

Caplin Point CRO successfully completes USFDA audit

Ruchika Sharma25 Sept 2021 1:55 PM IST
Chennai: Caplin Point Laboratories Limited has recently announced that Amaris Clinicals, the Clinical Research Organization (CRO) division...
Zydus Cadila arm gets USFDA nod for plaque psoriasis drug Apremilast

Zydus Cadila arm gets USFDA nod for plaque psoriasis drug Apremilast

Ruchika Sharma25 Sept 2021 12:57 PM IST
Ahmedabad: Drugmaker Zydus Cadila has recently announced that the company's U. S. subsidiary Zydus Pharmaceuticals Inc. has received final approval...
FIRST: Pfizer, BioNTech get USFDA emergency use nod for COVID vaccine booster

FIRST: Pfizer, BioNTech get USFDA emergency use nod for COVID vaccine booster

Ruchika Sharma23 Sept 2021 11:30 AM IST
New York: Pfizer Inc. and BioNTech SE have recently announced that the U.S. Food and Drug Administration (USFDA) has authorized for emergency use...
Roche antibody cocktail for post-exposure prophylaxis of Covid-19 for adults gets CDSCO panel okay

Roche antibody cocktail for post-exposure prophylaxis of Covid-19 for adults gets CDSCO panel okay

Medical Dialogues Team21 Sept 2021 5:05 PM IST
New Delhi: With the aim of reducing the spread of the Covid-19 epidemic, the Subject Expert Committee (SEC), functional under the Central Drug...
Glenmark bags USFDA nod for Clindamycin Phosphate Foam

Glenmark bags USFDA nod for Clindamycin Phosphate Foam

Ruchika Sharma21 Sept 2021 1:23 PM IST
Mumbai: Drugmaker, Glenmark Pharmaceuticals Ltd., announced that the company has received final approval from the United States Food & Drug...
Lupin Goa facility gets 7 USFDA observations

Lupin Goa facility gets 7 USFDA observations

Ruchika Sharma20 Sept 2021 12:41 PM IST
Mumbai: Global Pharma major, Lupin, has recently announced that the United States Food and Drug Administration (USFDA) has concluded an inspection...
Erbitux, adagrasib combination shrinks tumors in 39 percent of colon cancer patients: Mirati Therapeutics

Erbitux, adagrasib combination shrinks tumors in 39 percent of colon cancer patients: Mirati Therapeutics

Ruchika Sharma20 Sept 2021 10:15 AM IST
New Delhi: A combination of Mirati Therapeutics Inc's genetic mutation-targeting adagrasib and older cancer drug Erbitux shrank tumors in 39% of...
Zydus Cadila gets USFDA nod for depression drug Vortioxetine

Zydus Cadila gets USFDA nod for depression drug Vortioxetine

Ruchika Sharma19 Sept 2021 11:00 AM IST
Ahmedabad: Drugmaker, Zydus Cadila, has recently announced that the company has received final approval from the United States Food and Drug...
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