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Tag: usfda

You Searched For "usfda"
Sanofi Dupixent wins USFDA nod for atopic dermatitis

Sanofi Dupixent wins USFDA nod for atopic dermatitis

Ruchika Sharma8 Jun 2022 1:00 PM IST
Dupixent is administered as an injection under the skin (subcutaneous injection) at different injection sites.
Novavax COVID shot gets USFDA Advisory Committee recommendation for emergency use nod for 18 years and older

Novavax COVID shot gets USFDA Advisory Committee recommendation for emergency use nod for 18 years and older

Ruchika Sharma8 Jun 2022 12:14 PM IST
NVX-CoV2373 is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease.
Zydus Lifesciences Topical acne treatment gel gets USFDA okay

Zydus Lifesciences Topical acne treatment gel gets USFDA okay

Ruchika Sharma7 Jun 2022 1:10 PM IST
The drug will be manufactured at group’s topical facility at Ahmedabad.
Aurobindo Pharma arm bags USFDA nod for Leuprolide Acetate Injection

Aurobindo Pharma arm bags USFDA nod for Leuprolide Acetate Injection

Ruchika Sharma7 Jun 2022 12:46 PM IST
Leuprolide Acetate for injection is indicated for the treatment used to treat the symptoms associated with advanced prostate cancer by way of...
GSK application to expand use of Nucala for COPD accepted for review by EMA

GSK Measles vaccine Priorix bags USFDA okay

Ruchika Sharma6 Jun 2022 3:00 PM IST
Measles, mumps and rubella are acute and highly-contagious viral diseases responsible for considerable morbidity and mortality throughout the world.
Pfizer Myfembree sNDA accepted by USFDA for review

Pfizer Myfembree sNDA accepted by USFDA for review

Ruchika Sharma6 Jun 2022 2:15 PM IST
MYFEMBREE was approved in the U.S. in 2021 for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women with...
Karkinos Healthcare launches HPV test CerviRaksha priced at Rs 2499

Karkinos Healthcare launches HPV test CerviRaksha priced at Rs 2499

Ruchika Sharma6 Jun 2022 1:26 PM IST
CerviRaksha HPV test identifies the high-risk HPV-16 and HPV-18 genotypes individually.
USFDA nod to Zydus Lifesciences Famotidine Tablets

USFDA nod to Zydus Lifesciences Famotidine Tablets

Ruchika Sharma6 Jun 2022 11:36 AM IST
It is used to prevent and treat heartburn and other symptoms caused by excessive acid in the stomach (acid indigestion).
Bristol Myers Squibb withdraws supplemental biologics license application for Reblozyl for Non-transfusion Dependent (NTD) Beta Thalassemia

Bristol Myers Squibb withdraws supplemental biologics license application for Reblozyl for Non-transfusion Dependent (NTD) Beta Thalassemia

Ruchika Sharma5 Jun 2022 5:00 PM IST
Reblozyl, a first-in-class therapeutic option, is currently approved in the United States, European Union and Canada to address transfusion-dependent...
USFDA flags heart inflammation risk after taking Novavax COVID vaccine

USFDA flags heart inflammation risk after taking Novavax COVID vaccine

Ruchika Sharma4 Jun 2022 3:09 PM IST
The FDA said it had requested Novavax to flag myocarditis and another kind of heart inflammation as an "important identified risk" in its materials.
Pfizer-BioNTech seeks USFDA authorisation for COVID vaccine for kids under 5 years

Pfizer-BioNTech seeks USFDA authorisation for COVID vaccine for kids under 5 years

Ruchika Sharma3 Jun 2022 11:30 AM IST
No COVID-19 shot is yet approved for children in that age group in most parts of the world.
Sanofi gets USFDA breakthrough therapy designation for hemophilia A drug Efanesoctocog alfa

Sanofi gets USFDA breakthrough therapy designation for hemophilia A drug Efanesoctocog alfa

Ruchika Sharma2 Jun 2022 5:03 PM IST
Hemophilia A occurs in about one in 5,000 male births annually, and more rarely in females.
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