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Tag: usfda

You Searched For "usfda"
Pfizer secures USFDA priority review for RSV vaccine for older adults

Pfizer secures USFDA priority review for RSV vaccine for older adults

Ruchika Sharma8 Dec 2022 3:00 PM IST
RSV is a contagious virus and a common cause of respiratory illness.
Pfizer, BioNTech seek USFDA emergency use nod for Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine in children under 5 years

Pfizer, BioNTech seek USFDA emergency use nod for Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine in children under 5 years

Ruchika Sharma6 Dec 2022 11:30 AM IST
New York: Pfizer and BioNTech have announced that the companies have submitted an application to the U.S. Food and Drug Administration (USFDA) for...
Sun Pharma, Dr Reddys Labs recall products in US over manufacturing issues

Sun Pharma, Dr Reddy's Labs recall products in US over manufacturing issues

Ruchika Sharma5 Dec 2022 1:30 PM IST
The health regulator further said the US-based arm of Sun Pharma is recalling 14,064 cartons of a medication to treat erosive esophagitis or heartburn...
Regeneron Pharma Evkeeza under USFDA priority review for children with Ultra-rare inherited form of high cholesterol

Regeneron Pharma Evkeeza under USFDA priority review for children with Ultra-rare inherited form of high cholesterol

Ruchika Sharma4 Dec 2022 2:15 PM IST
Tarrytown: Regeneron Pharmaceuticals, Inc. has announced the U.S. Food and Drug Administration (USFDA) has accepted for Priority Review the...
USFDA rejects Y-mAbs Therapeutics pediatric cancer drug Omburtamab

USFDA rejects Y-mAbs Therapeutics pediatric cancer drug Omburtamab

Ruchika Sharma3 Dec 2022 1:30 PM IST
Omburtamab was being developed to treat cancer in the cerebrospinal fluid that provides nutrients and chemicals to the brain and spinal cord.
Elon Musks Neuralink implant that will convert brains into organic computer 6 month away from human trial

Elon Musk's Neuralink implant that will convert brains into organic computer 6 month away from human trial

Roshni Dhar2 Dec 2022 5:30 PM IST
Elon Musk's Neuralink Corp. aims to start putting its coin-sized computing brain implant into human patients within six months, the company announced...
Zydus Lifesciences secures USFDA approval for Estradiol Transdermal System to treat menopause symptoms

Zydus Lifesciences secures USFDA approval for Estradiol Transdermal System to treat menopause symptoms

Ruchika Sharma2 Dec 2022 3:43 PM IST
Ahmedabad: Pharma major Zydus Lifesciences Limited (formerly known as Cadila Healthcare Limited) has announced that the company has received final ...
Alembic Pharma gets four USFDA observations for Panelav facility

Alembic Pharma osteoarthritis drug gets USFDA okay

Ruchika Sharma1 Dec 2022 5:45 PM IST
Diclofenac Sodium Topical Solution is indicated for the treatment of the pain of osteoarthritis of the knee(s).
USFDA approves first Fecal Microbiota product REBYOTA from Ferring Pharma

USFDA approves first Fecal Microbiota product REBYOTA from Ferring Pharma

Ruchika Sharma1 Dec 2022 12:15 PM IST
REBYOTA is a pre-packaged, single-dose 150 mL microbiota suspension for rectal administration.
USFDA nod to Zydus Lifesciences Migraine drug Topiramate Extended Release

USFDA nod to Zydus Lifesciences Migraine drug Topiramate Extended Release

Ruchika Sharma1 Dec 2022 11:16 AM IST
The drug will be manufactured at the group's formulation manufacturing facility at Ahmedabad SEZ, India.
JB Pharma bags USFDA nod for Major Depressive Disorder drug Venlafaxine Extended Release

JB Pharma bags USFDA nod for Major Depressive Disorder drug Venlafaxine Extended Release

Ruchika Sharma30 Nov 2022 3:30 PM IST
A selective serotonin and norepinephrine reuptake inhibitor (SNRI), Venlafaxine Extended-Release tablets are indicated for Major Depressive Disorder...
Cipla unveils Leuprolide Acetate Injection Depot for advanced prostate cancer in US

Cipla unveils Leuprolide Acetate Injection Depot for advanced prostate cancer in US

Ruchika Sharma29 Nov 2022 1:00 PM IST
Mumbai: Pharma major Cipla Limited and its wholly owned subsidiary Cipla USA Inc., today announced the launch of Leuprolide Acetate Injection Depot ...
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