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7124 News Found

Lupin receives tentative approval from USFDA for DETAF tablets
Drug Approval | February 01, 2023

Lupin receives tentative approval from USFDA for DETAF tablets

DETAF would be a welcome new addition in the management of HIV infections and will be available for supplies to low- and middle-income countries


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


USFDA provides exception to Glenmark's Baddi facility
Drug Approval | January 28, 2023

USFDA provides exception to Glenmark's Baddi facility

The company will engage with the agency to resolve the import alert at the earliest.


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.


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


G 20: Medical Value Travel could be focused on maintaining, improving or restoring health through medical intervention: Dr V K Paul
Policy | January 21, 2023

G 20: Medical Value Travel could be focused on maintaining, improving or restoring health through medical intervention: Dr V K Paul

There is a great opportunity for utilizing traditional medical practices like Ayurveda in Value Based Healthcare


ProBioGen’s vaccine production cell line AGE1.CR.pIX used for clinical production
News | January 20, 2023

ProBioGen’s vaccine production cell line AGE1.CR.pIX used for clinical production

The AGE1.CR.pIX cell line is derived from primary cells of a duck embryo and was designed to comply with health authority guidelines


Stelis Biopharma’s flagship facility receives EIR from USFDA
Drug Approval | January 19, 2023

Stelis Biopharma’s flagship facility receives EIR from USFDA

The company is excited about the strategic progress that the company has made so far and are confident of delivering better business outcomes