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Tag: usfda

You Searched For "usfda"
Zydus Lifesciences US arm wins USFDA nod for Levothyroxine Sodium for Injection to treat myxedema coma

Zydus Lifesciences US arm wins USFDA nod for Levothyroxine Sodium for Injection to treat myxedema coma

Ruchika Sharma28 Nov 2022 11:32 AM IST
The drug will be manufactured at the group's injectable manufacturing facility at Jarod, near Vadodara, India.
USFDA declines to approve Spectrum Pharma lung cancer drug Poziotinib

USFDA declines to approve Spectrum Pharma lung cancer drug Poziotinib

Ruchika Sharma26 Nov 2022 4:04 PM IST
Boston: Spectrum Pharmaceuticals, Inc., a biopharmaceutical company focused on novel and targeted oncology therapies, has announced that the...
Worlds most expensive drug: USFDA nod to HEMGENIX worth USD 3.5 million a dose

World's most expensive drug: USFDA nod to HEMGENIX worth USD 3.5 million a dose

Roshni Dhar25 Nov 2022 5:41 PM IST
Global biotechnology leader CSL has announced that the U.S. Food and Drug Administration (USFDA) has approved HEMGENIX (etranacogene...
Health Bulletin 25/November/2022

Health Bulletin 25/November/2022

Roshni Dhar25 Nov 2022 4:51 PM IST
Here are the top health news for the day:Thirteen measles deaths reported in Mumbai An eight-year-old boy from Govandi died on Thursday due to...
Natco Pharma gets 7 USFDA observations for Kothur Pharma Division

Lupin gets 8 USFDA observations for Mandideep facility

Ruchika Sharma25 Nov 2022 11:00 AM IST
Mumbai: Lupin has recently announced that the US Food and Drug Administration (USFDA) has concluded an inspection with eight observations each...
Caplin Steriles gets USFDA nod for Procainamide Hydrochloride Injection for treating abnormal heart rhythm

FIRST: CSL bags USFDA approval for HEMGENIX to treat hemophilia B

Ruchika Sharma25 Nov 2022 11:00 AM IST
Hemophilia B is a rare, lifelong bleeding disorder caused by a single gene defect, resulting in insufficient production of factor IX, a protein...
Baxter hospital bed systems recall classified as most serious by USFDA

Baxter hospital bed systems recall classified as most serious by USFDA

Ruchika Sharma24 Nov 2022 2:30 PM IST
The device was found to interfere with other nearby critical devices such as infusion pumps, insulin pumps, blood glucose sensors, and bladder...
Cipla gets USFDA OAI status for Goa facility

Cipla gets USFDA OAI status for Goa facility

Ruchika Sharma24 Nov 2022 1:30 PM IST
Mumbai: Pharma major Cipla has announced that the company has received a communication from the US Food and Drug Administration (USFDA) that the...
USFDA inspection: Glenmark Pharma gets warning letter for Goa facility

USFDA inspection: Glenmark Pharma gets warning letter for Goa facility

Ruchika Sharma24 Nov 2022 12:30 PM IST
Mumbai: Drugmaker Glenmark Pharma has recently announced that the US Food and Drug Administration (USFDA) has issued a warning letter to the...
Takeda Dengue Vaccine TAK-003 gets USFDA priority review

Takeda Dengue Vaccine TAK-003 gets USFDA priority review

Ruchika Sharma23 Nov 2022 5:00 PM IST
Takeda's tetravalent dengue vaccine candidate (TAK-003) is based on a live-attenuated dengue serotype 2 virus, which provides the genetic "backbone"...
USFDA nod to Zydus Lifesciences Famotidine Injection

USFDA nod to Zydus Lifesciences Famotidine Injection

Ruchika Sharma23 Nov 2022 4:16 PM IST
Famotidine Injection is indicated to treat ulcers of the stomach and intestines and to prevent intestinal ulcers from coming back after they have...
Dr Reddys Labs gets USFDA EIR for Miryalaguda facility

Dr Reddys beats Aurobindo Pharma to become second biggest drug maker in India: Report

Farhat Nasim22 Nov 2022 6:36 PM IST
New Delhi: A change in the ranking of India's USD 50 billion pharma industry in over 7 years was witnessed as Hyderabad-based Dr Reddy's...
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