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Tag: usfda

You Searched For "usfda"
Gilead Biktarvy expanded indication for HIV-1 treatment in pediatrics gets USFDA okay

Gilead Biktarvy expanded indication for HIV-1 treatment in pediatrics gets USFDA okay

Ruchika Sharma20 Oct 2021 2:32 PM IST
Foster City: Gilead Sciences, Inc. has announced that the U.S. Food and Drug Administration (USFDA) has approved a new low-dose tablet dosage form of...
USFDA panel mulls mixing, matching Covid-19 vaccine doses

USFDA panel mulls mixing, matching Covid-19 vaccine doses

MD Bureau20 Oct 2021 10:00 AM IST
Washington: After endorsing both Moderna and Johnson & Johnson's Covid booster doses last week, the US Food and Drug Administration is now...
Oyster Point Pharma secures USFDA approval for TYRVAYA nasal spray to treat dry eye disease

Oyster Point Pharma secures USFDA approval for TYRVAYA nasal spray to treat dry eye disease

Ruchika Sharma19 Oct 2021 1:01 PM IST
Each nasal spray bottle covers treatment for 15 days, administered twice daily into each nostril.
Dr Reddys Labs bags USFDA okay for Lenalidomide capsules

Dr Reddy's Labs bags USFDA okay for Lenalidomide capsules

Ruchika Sharma19 Oct 2021 11:45 AM IST
Hyderabad: Drugmaker, Dr. Reddy's Laboratories Ltd., today announced the final approval of its Abbreviated New Drug Application (ANDA) for ...
Exelixis in-licenses 2nd anti-cancer compound from Aurigene

Exelixis in-licenses 2nd anti-cancer compound from Aurigene

Ruchika Sharma18 Oct 2021 1:27 PM IST
Alameda: Exelixis, Inc. and Aurigene Discovery Technologies Limited have announced that Exelixis has exercised its exclusive option under the...
Boehringer Ingelheim Cyltezo gets USFDA nod as 1st iterchangeable biosimilar with Humira

Boehringer Ingelheim Cyltezo gets USFDA nod as 1st iterchangeable biosimilar with Humira

Ruchika Sharma17 Oct 2021 11:00 AM IST
Ridgefield: Boehringer Ingelheim has recently announced that the U.S. Food and Drug Administration (USFDA) has approved the supplemental Biologics...
Dr Reddys launches Carmustine for Injection in US

Dr Reddys launches Carmustine for Injection in US

Ruchika Sharma16 Oct 2021 3:16 PM IST
Hyderabad: Pharma major, Dr Reddy's Laboratories Ltd., has recently announced the launch of Carmustine for Injection, USP.The product is a therapeutic...
Abbott Labs unit recalls 2 COVID lab test kits over false positive results

Abbott Labs unit recalls 2 COVID lab test kits over false positive results

Ruchika Sharma16 Oct 2021 1:00 PM IST
An overflow of one patient sample into another while mixing chemicals with the samples could be related to the false positive results, the FDA said on...
Analysis of JnJ COVID booster data by USFDA scientists raises red flags

Analysis of JnJ COVID booster data by USFDA scientists raises red flags

Ruchika Sharma14 Oct 2021 12:30 PM IST
US: U.S. Food and Drug Administration scientists said on Wednesday they did not receive enough data in time to do their own analysis of Johnson &...
Eli Lilly gets USFDA nod to Verzenio as adjuvant therapy for breast cancer patients

Eli Lilly gets USFDA nod to Verzenio as adjuvant therapy for breast cancer patients

Ruchika Sharma14 Oct 2021 12:00 PM IST
Indianapolis: Eli Lilly and Company has recently announced that the U.S.Food and Drug Administration (USFDA) has approved the...
Moderna did not meet all criteria for Covid-19 boosters, says USFDA staff

Moderna did not meet all criteria for Covid-19 boosters, says USFDA staff

Ruchika Sharma14 Oct 2021 10:00 AM IST
US: Scientists at the U.S. Food and Drug Administration said on Tuesday that Moderna Inc had not met all of the agency's criteria to support use of...
JnJ, Moderna COVID vaccine third dose efficacy to be evaluated by USFDA this week

JnJ, Moderna COVID vaccine third dose efficacy to be evaluated by USFDA this week

MD Bureau13 Oct 2021 2:00 PM IST
Washington: The US Food and Drug Administration is expected to evaluate the efficacy of Moderna and Johnson & Johnson's third dose of Covid...
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