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Results For "Food-and-Drug-Administration"

1074 News Found

ENHERTU approved in the U.S. as the first HER2 directed for low metastatic breast cancer
Drug Approval | August 09, 2022

ENHERTU approved in the U.S. as the first HER2 directed for low metastatic breast cancer

Based on DESTINY-Breast04 results which showed Daiichi Sankyo and AstraZeneca’s ENHERTU reduced risk of disease progression or death by 50% and increased overall survival by more than six months versus chemotherapy


Biocon Sdn. Bhd. enters Malaysia Book of Records
Biotech | August 08, 2022

Biocon Sdn. Bhd. enters Malaysia Book of Records

The 562,000 square feet facility has been recognized as the first and largest integrated insulin manufacturer in Malaysia by MBR


Zydus receives final approval from the USFDA for Ivermectin Cream
Drug Approval | August 04, 2022

Zydus receives final approval from the USFDA for Ivermectin Cream

Ivermectin Cream is a used for the treatment of inflammatory lesions of rosacea.


Jubilant Pharmova gets 6 observations from USFDA for its facility at Roorkee
News | August 03, 2022

Jubilant Pharmova gets 6 observations from USFDA for its facility at Roorkee

he US FDA has issued six observations pursuant to the completion of the audit.


USFDA issues 3 observations for Aurobindo Pharma’s Unit XI
Drug Approval | August 03, 2022

USFDA issues 3 observations for Aurobindo Pharma’s Unit XI

The company has responded to the warning letter and carried out the committed corrections.


Casper Pharma completed USFDA pre-approval inspection
Drug Approval | July 31, 2022

Casper Pharma completed USFDA pre-approval inspection

The audit is part of the agency's inspection for three product applications filed and slated to be manufactured at this site.


Dr. Reddy's launches Bortezomib for Injection, 3.5 mg Single-Dose Vial in the U.S. Market
Drug Approval | July 28, 2022

Dr. Reddy's launches Bortezomib for Injection, 3.5 mg Single-Dose Vial in the U.S. Market

The Velcade Brand and generic had U.S. sales of approximately $1.2 billion MAT for the most recent twelve months ending in May 2022


Lupin receives approval from U.S. FDA for Azilsartan Medoxomil Tablets
Drug Approval | July 26, 2022

Lupin receives approval from U.S. FDA for Azilsartan Medoxomil Tablets

The product will be manufactured at Lupin's facility in Nagpur, India.


Zydus receives final approval from the USFDA for Bisoprolol Fumarate Tablets
Drug Approval | July 26, 2022

Zydus receives final approval from the USFDA for Bisoprolol Fumarate Tablets

Bisoprolol Fumarate Tablets are used to treat high blood pressure.


Sun Pharma and Cosmo announce territory expansion of license and supply agreements for WINLEVI
Supply Chain | July 26, 2022

Sun Pharma and Cosmo announce territory expansion of license and supply agreements for WINLEVI

Sun Pharma will receive from Cassiopea the exclusive right to develop and commercialize WINLEVI in Japan, Australia, New Zealand, Brazil, Mexico and Russia.