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Tag: usfda

You Searched For "usfda"
Dr Reddys Labs unveils Sorafenib Tablets in US

Dr Reddy's Labs unveils Sorafenib Tablets in US

Ruchika Sharma14 Jun 2022 2:42 PM IST
Dr Reddy's Sorafenib Tablets, USP, are available in 200 mg tablets in bottle count sizes of 120.
FIRST: Eli Lilly gets USFDA nod for alopecia areata pill Olumiant

FIRST: Eli Lilly gets USFDA nod for alopecia areata pill Olumiant

Ruchika Sharma14 Jun 2022 1:00 PM IST
OLUMIANT is a once-daily, oral JAK inhibitor discovered by Incyte and licensed to Lilly and is available through specialty pharmacies nationwide.
Merck seeks USFDA nod for Keytruda to treat non-small cell lung cancer

Merck seeks USFDA nod for Keytruda to treat non-small cell lung cancer

Ruchika Sharma14 Jun 2022 12:00 PM IST
KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body's immune system to help detect and...
Pfizer-BioNTech COVID vaccines effective, safe for children aged 6 months to 4 years: USFDA staff

Pfizer-BioNTech COVID vaccines effective, safe for children aged 6 months to 4 years: USFDA staff

Ruchika Sharma13 Jun 2022 1:45 PM IST
An early analysis of data from Pfizer-BioNTech's vaccine based on 10 symptomatic COVID-19 cases identified when the Omicron coronavirus variant was...
Strides Pharma recalls BP lowering drug Losartan Potassium in US over manufacturing issues

Strides Pharma recalls BP lowering drug Losartan Potassium in US over manufacturing issues

Ruchika Sharma13 Jun 2022 10:45 AM IST
As per the USFDA, the company has initiated the Class II recall due to "CGMP (current good manufacturing practices) deviations".
USFDA panel backs Bluebird bio gene therapy for blood disorder

USFDA panel backs Bluebird bio gene therapy for blood disorder

Ruchika Sharma12 Jun 2022 12:00 PM IST
The FDA is expected to decide on beti-cel's fate by Aug. 19 and eli-cel's by Sept. 16. The agency is not required to follow its advisers'...
Panacea Biotec arm gets 8 USFDA observations for Baddi facility

Panacea Biotec arm gets 8 USFDA observations for Baddi facility

Ruchika Sharma11 Jun 2022 5:15 PM IST
Punjab: Panacea Biotec has recently announced that its material wholly-owned subsidiary, Panacea Biotec Pharma Limited ("PBPL") has received...
Moderna coronavirus vaccine effective for kids under five years: USFDA

Moderna coronavirus vaccine effective for kids under five years: USFDA

Ruchika Sharma11 Jun 2022 2:15 PM IST
Even though Moderna's vaccine has proven less effective against the Omicron variant, it remains very good at protecting against severe cases of the...
USFDA nod to Alembic Pharma cancer drug Dasatinib

USFDA nod to Alembic Pharma cancer drug Dasatinib

Ruchika Sharma10 Jun 2022 12:58 PM IST
Vadodara: Drugmaker, Alembic Pharmaceuticals Limited, today announced that the company has received tentative approval from the US Food & Drug...
Abbott Healthcare faces 5 year ban from Tamil Nadu Govt agency: Report

Abbott Healthcare faces 5 year ban from Tamil Nadu Govt agency: Report

Farhat Nasim9 Jun 2022 11:00 AM IST
Chennai: Coming down heavily on Abbott Healthcare, the Tamil Nadu Medical Services Corporation (TNMSC) has placed the company on 5-year ban list for...
Eli Lilly sued by whistleblower over drug manufacturing problems

Eli Lilly sued by whistleblower over drug manufacturing problems

Ruchika Sharma8 Jun 2022 3:27 PM IST
The company also said it "continues to cooperate" with a Justice Department subpoena and to work collaboratively with the U.S. Food and Drug...
Lupin bags USFDA nod for cystic fibrosis drug Ivacaftor

Lupin bags USFDA nod for cystic fibrosis drug Ivacaftor

Ruchika Sharma8 Jun 2022 2:47 PM IST
This product will be manufactured at Lupin’s Nagpur facility in India.
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