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Results For "USFDA"

1133 News Found

Briefs: Eugia Steriles and Shelter Pharma
Drug Approval | September 18, 2024

Briefs: Eugia Steriles and Shelter Pharma

Eugia Steriles receives EIR from USFDA for new injectable facility


Global Bio India unveils 30 breakthrough startups: Dr. Jitendra Singh
Policy | September 14, 2024

Global Bio India unveils 30 breakthrough startups: Dr. Jitendra Singh

India's bio economy has experienced remarkable growth, skyrocketing from US $10 billion in 2014 to over $130 billion in 2024, with projections to reach $300 billion by 2030


Briefs: Medicamen Biotech, Aurobindo Pharma and Ajooni Biotech
News | September 12, 2024

Briefs: Medicamen Biotech, Aurobindo Pharma and Ajooni Biotech

The sANDA was submitted as “Prior Approval Supplement” for addition of an alternate drug product manufacturing, labeling, packaging, and testing facility


Zydus Lifesciences announces completion of Phase II(a) clinical trial of Usnoflast
Diagnostic Center | September 11, 2024

Zydus Lifesciences announces completion of Phase II(a) clinical trial of Usnoflast

ALS patients experience neuroinflammation and rapid neurodegeneration


Briefs: Ami Organics and Dr. Reddy’s Laboratories
Drug Approval | September 09, 2024

Briefs: Ami Organics and Dr. Reddy’s Laboratories

Ami informs that PMDA Japan has issued Inspection Result Report declaring the Sachin facility as a Good Manufacturing Practices (GMP) compliant.


Lupin launches Doxorubicin Hydrochloride Liposome Injection in US
Drug Approval | September 03, 2024

Lupin launches Doxorubicin Hydrochloride Liposome Injection in US

ForDoz Pharma Corporation, USA (ForDoz) received an approval for its ANDA from the USFDA


Suven Life Sciences announces FDA acceptance of investigational new drug
Drug Approval | August 30, 2024

Suven Life Sciences announces FDA acceptance of investigational new drug

First-in-human Phase-1 study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of SUVN-I6107 in healthy subjects


Shilpa Medicare announces positive outcome of Phase 3 studies of NorUDCA
Diagnostic Center | August 26, 2024

Shilpa Medicare announces positive outcome of Phase 3 studies of NorUDCA

Nor UDCA is likely to be a first-in-class treatment option for NAFLD in India


Wanbury receives EIR from FDA for Patalganga facility
Drug Approval | August 23, 2024

Wanbury receives EIR from FDA for Patalganga facility

USFDA has determined that the inspection classification of this facility is "No Action Indicated" (NAI) with zero 483 observation