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Tag: usfda

You Searched For "usfda"
Medtronic gets USFDA nod for OmniaSecure defibrillation lead for placement within right ventricle

Medtronic MiniMed 780G System bags USFDA okay

Ruchika Sharma24 April 2023 4:30 PM IST
It's the pump with an infusion set that can be worn for up to 7 days, doubling wear time with advanced materials that help reduce insulin preservative...
Novartis oral Fabhalta gets USFDA nod for adults with C3 glomerulopathy

Novartis Millburn facility gets USFDA nod for US commercial production of Pluvicto

Ruchika Sharma24 April 2023 2:15 PM IST
United States: Novartis has received US Food and Drug Administration (FDA) approval to begin supplying Pluvicto for US commercial use from the...
Hetero, Sun Pharma recall products in US over manufacturing issues

Hetero, Sun Pharma recall products in US over manufacturing issues

Ruchika Sharma24 April 2023 12:15 PM IST
Hetero USA Inc is recalling 2,352 bottles of Pantoprazole Sodium delayed release tablets for "CGMP Deviations: Discoloration", the USFDA stated.
USFDA approves Zydus Lifesciences Icosapent Ethyl Capsules

USFDA approves Zydus Lifesciences Icosapent Ethyl Capsules

Ruchika Sharma24 April 2023 11:15 AM IST
Ahmedabad: Drugmaker, Zydus Lifesciences Limited, has recently announced that the company has received final approval from the United States Food and...
USFDA extends review period for Daiichi Sankyo acute myeloid leukemia drug Quizartinib

USFDA extends review period for Daiichi Sankyo acute myeloid leukemia drug Quizartinib

Ruchika Sharma23 April 2023 4:00 PM IST
Quizartinib is an oral, highly potent type II FLT3 inhibitor that selectively targets FLT3-ITD mutations and has been specifically developed for...
GE HealthCare CARESCAPE Canvas Patient Monitoring Platform gets USFDA clearance

GE HealthCare CARESCAPE Canvas Patient Monitoring Platform gets USFDA clearance

Ruchika Sharma23 April 2023 2:00 PM IST
CARESCAPE Canvas is a FlexAcutity solution equipped with smart parameter technology that can be used for patients at all levels of acuity.
Dr Reddys Labs inks pact with Henlius for commercialization of multiple myeloma injection HLX15 in US, Europe

Dr Reddy's Labs unveils Treprostinil Injection in US

Ruchika Sharma22 April 2023 12:30 PM IST
Hyderabad: Dr. Reddy's Laboratories Ltd. has announced the launch of Treprostinil Injection in the U.S. market, a therapeutic equivalent generic ...
USFDA authorizes second Omicron-updated COVID booster for older adults

USFDA authorizes second Omicron-updated COVID booster for older adults

Ruchika Sharma20 April 2023 4:30 PM IST
US: The U.S. Food and Drug Administration on Tuesday authorized a second dose of Omicron-targeting COVID-19 vaccines for older adults as well as those...
No Waiver for Faricimab: CDSCO Panel Asks Roche to Conduct Phase III Trial in India

USFDA nod to Roche's Polivy in combination with R-CHP for certain types of previously untreated diffuse large B-cell lymphoma

Ruchika Sharma20 April 2023 2:30 PM IST
Polivy is a first-in-class anti-CD79b antibody-drug conjugate.
Hypertension drug: Zydus Lifesciences gets USFDA approval for Metoprolol Tartrate Tablets

Hypertension drug: Zydus Lifesciences gets USFDA approval for Metoprolol Tartrate Tablets

Ruchika Sharma20 April 2023 12:22 PM IST
This medication is also used to treat chest pain (angina) and to improve survival after a heart attack.
Zydus Lifesciences bags USFDA nod for pulmonary drug Roflumilast

Zydus Lifesciences bags USFDA nod for pulmonary drug Roflumilast

Ruchika Sharma20 April 2023 11:33 AM IST
The drug will be manufactured at the group's formulation manufacturing facility in SEZ Ahmedabad, India.
Natco Pharma gets 7 USFDA observations for Kothur Pharma Division

Piramal Pharma gets USFDA EIR for Sellersville facility

Ruchika Sharma19 April 2023 2:46 PM IST
Mumbai: Piramal Pharma has recently announced that the US Food and Drug Administration (USFDA) has successfully concluded the inspection of the...
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