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Tag: usfda

You Searched For "usfda"
USFDA nod to Zydus Lifesciences Pitavastatin Tablets

USFDA nod to Zydus Lifesciences Pitavastatin Tablets

Ruchika Sharma25 Feb 2023 11:24 AM IST
Ahmedabad: Zydus Lifesciences Limited has announced that the company has received final approval from the United States Food and Drug Administration ...
USFDA grants priority review to Pfizer Elranatamab for relapsed or refractory multiple myeloma

USFDA grants priority review to Pfizer Elranatamab for relapsed or refractory multiple myeloma

Ruchika Sharma24 Feb 2023 2:30 PM IST
Elranatamab is an investigational, off-the-shelf, humanized BCMA CD3-targeted BsAb.
Pfizer Told To Conduct Phase IV Trial of Abrocitinib in Indian Adolescents with Atopic Dermatitis

Pfizer Respiratory Syncytial Virus Maternal Vaccine candidate gets USFDA priority review

Ruchika Sharma24 Feb 2023 1:30 PM IST
RSV is a contagious virus and a common cause of respiratory illness.
Sanofi Dupixent

Sanofi gets USFDA nod for hemophilia A treatment ALTUVIIIO

Ruchika Sharma24 Feb 2023 12:19 PM IST
Hemophilia A is a rare, lifelong condition in which the ability of a person's blood to clot properly is impaired, leading to excessive bleeds and...
Strides Pharma Science Bangalore facility gets USFDA inspection closure

Strides Pharma Science Bangalore facility gets USFDA inspection closure

Ruchika Sharma24 Feb 2023 11:19 AM IST
The flagship facility in Bangalore is the largest manufacturing facility for the company, with the capability to produce finished dosage formulation...
Moderna-Merck gets USFDA Breakthrough Therapy Designation for personalized mRNA cancer vaccine in combination with KEYTRUDA to treat high risk melanoma

Moderna-Merck gets USFDA Breakthrough Therapy Designation for personalized mRNA cancer vaccine in combination with KEYTRUDA to treat high risk melanoma

Ruchika Sharma23 Feb 2023 2:45 PM IST
Cambridge: Moderna, Inc. and Merck have announced that mRNA-4157/V940, an investigational personalized mRNA cancer vaccine, in combination with...
Hyderabad home to maximum USFDA approved pharma companies in world

Hyderabad home to maximum USFDA approved pharma companies in world

MD Bureau22 Feb 2023 11:30 AM IST
KTR said the Telangana government has set the ambitious goal of doubling the size of the life sciences sector to $100 billion by 2028.
USFDA clears Strykers Q Guidance System with Cranial Guidance Software

USFDA clears Stryker's Q Guidance System with Cranial Guidance Software

Ruchika Sharma21 Feb 2023 12:30 PM IST
The Cranial Guidance Software is powered by Stryker's Q Guidance System and can be used with a range of instruments and accessories for navigated...
Zydus Lifesciences arm bags tentative approval from USFDA for Canagliflozin, Metformin Hydrochloride Tablets

Zydus Lifesciences arm bags tentative approval from USFDA for Canagliflozin, Metformin Hydrochloride Tablets

Ruchika Sharma20 Feb 2023 4:30 PM IST
The drug will be manufactured at the group's formulation manufacturing facility at Moraiya.
Natco Pharma gets 7 USFDA observations for Kothur Pharma Division

USFDA inspection: Cipla gets 8 observations for Pithampur facility

Ruchika Sharma20 Feb 2023 12:15 PM IST
Mumbai: Cipla has recently announced that the United States Food and Drug Administration (USFDA) has issued 8 inspectional observations in Form 483...
Zydus Lifesciences arm gets USFDA nod for Postherpetic Neuralgia drug Gabapentin

Zydus Lifesciences arm gets USFDA nod for Postherpetic Neuralgia drug Gabapentin

Ruchika Sharma20 Feb 2023 11:19 AM IST
Ahmedabad: Pharma major Zydus Lifesciences Limited has announced that the company's subsidiary Zydus Pharmaceuticals (USA) Inc. has received tentative...
Merck gets USFDA priority review for PREVYMIS for Prophylaxis of Cytomegalovirus Disease in kidney transplant recipients at high risk

Merck gets USFDA priority review for PREVYMIS for Prophylaxis of Cytomegalovirus Disease in kidney transplant recipients at high risk

Ruchika Sharma19 Feb 2023 4:30 PM IST
Rahway: Merck, known as MSD outside of the United States and Canada, has announced that the U.S. Food and Drug Administration (FDA) has accepted for...
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