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Results For "Food-and-Drug-Administration"

1075 News Found

Alkem to launch novel antibiotic for MDR infections
News | January 31, 2023

Alkem to launch novel antibiotic for MDR infections

Zidavi is recommended by the Infectious Disease Society of America


FDA approves Keytruda as adjuvant treatment for non-small cell lung cancer
Drug Approval | January 30, 2023

FDA approves Keytruda as adjuvant treatment for non-small cell lung cancer

Approval marks fifth indication for KEYTRUDA-based regimens in NSCLC and 34th indication for KEYTRUDA in the US


USFDA inspection: Zydus Lifesciences and Gland Pharma
Drug Approval | January 28, 2023

USFDA inspection: Zydus Lifesciences and Gland Pharma

The United States Food and Drug Administration (USFDA) conducted an inspection at Gland Pharma Limited API Facility at JNPC, Visakhapatnam


Dr. Reddy's Laboratories launches Difluprednate Ophthalmic Emulsion 0.05% in US
News | January 28, 2023

Dr. Reddy's Laboratories launches Difluprednate Ophthalmic Emulsion 0.05% in US

The Durezol brand and generic had US sales of approximately US $40 million MAT for the most recent twelve months ending in Nov 2022 according to IQVIA


Sun Pharma launches SEZABY in the US for treatment of neonatal seizures
News | January 27, 2023

Sun Pharma launches SEZABY in the US for treatment of neonatal seizures

SEZABY is a benzyl alcohol-free and propylene glycol-free formulation of phenobarbital sodium powder for injection


USFDA inspection at Indoco Remedies's Solid Oral Formulation Facility at Goa
Drug Approval | January 24, 2023

USFDA inspection at Indoco Remedies's Solid Oral Formulation Facility at Goa

USFDA issued issued Form 483 with nine observations, which will be addressed within stipulated time.


Syngene Q3FY23 revenue reaches Rs. 803 Cr; PAT reaches Rs. 110 Cr
News | January 24, 2023

Syngene Q3FY23 revenue reaches Rs. 803 Cr; PAT reaches Rs. 110 Cr

The company is pleased to report positive performances from all divisions this quarter. Growth in our research divisions, Discovery Services and the Dedicated Centres was solid


Astellas announces hold lifted by FDA on Fortis clinical trial of AT845
Drug Approval | January 23, 2023

Astellas announces hold lifted by FDA on Fortis clinical trial of AT845

Astellas stands on the forefront of healthcare change to turn innovative science into value for patients


US FDA accepts supplemental new drug application for Jardiance for adults with chronic kidney disease
News | January 23, 2023

US FDA accepts supplemental new drug application for Jardiance for adults with chronic kidney disease

The supplemental New Drug Application is based on results from the landmark EMPA-KIDNEY phase III trial


USFDA completes inspection at APL HealthCare
Drug Approval | January 19, 2023

USFDA completes inspection at APL HealthCare

The company has been issued ‘Form 483’ with two observations