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Results For "US-FDA"

344 News Found

Novartis atrasentan Phase III data show clinically meaningful proteinuria reduction
Clinical Trials | May 27, 2024

Novartis atrasentan Phase III data show clinically meaningful proteinuria reduction

Through its rare kidney disease portfolio, Novartis is committed to exploring a range of treatment options with different modes of action to slow IgAN progression


Biocon Biologics’ receives FDA approval for Biosimilar Aflibercept for Yesafili
Drug Approval | May 21, 2024

Biocon Biologics’ receives FDA approval for Biosimilar Aflibercept for Yesafili

The approval of YESAFILI marks Biocon Biologics’ expansion into the ophthalmology therapeutic area in the United States


Briefs: Lupin and Aurobindo Pharma
News | May 13, 2024

Briefs: Lupin and Aurobindo Pharma

Lupin updates on shipment of Mirabegron ER Tablets


Alembic Pharmaceuticals receives EIR from USFDA for oncology formulation facility
Drug Approval | May 07, 2024

Alembic Pharmaceuticals receives EIR from USFDA for oncology formulation facility

With this, for all our USFDA facilities, EIRs are in place


Briefs: Eugia Pharma Specialities and IOL Chemicals and Pharmaceuticals
Drug Approval | May 06, 2024

Briefs: Eugia Pharma Specialities and IOL Chemicals and Pharmaceuticals

Eugia Pharma Specialities receives 7 observations from USFDA for Unit II


Granules India announced ANDA Approval for Colchicine Capsules
Drug Approval | May 01, 2024

Granules India announced ANDA Approval for Colchicine Capsules

Colchicine Capsules are indicated for prophylaxis of gout flares in adult


Positive data for Roche multiple sclerosis injection
Drug Approval | April 17, 2024

Positive data for Roche multiple sclerosis injection

US FDA and EMA accepted filings based on the data from OCARINA II, with EU approval anticipated mid-2024 and U.S. approval anticipated September 2024


Briefs: Sun Pharma and Kimia Biosciences
News | April 14, 2024

Briefs: Sun Pharma and Kimia Biosciences

Sun Pharma's Dadra facility receives OAI status from US FDA


Granules India’s Unit V facility in Visakhapatnam completes USFDA inspection with zero 483 observations
Drug Approval | April 14, 2024

Granules India’s Unit V facility in Visakhapatnam completes USFDA inspection with zero 483 observations

This facility manufactures APIs & formulations of oncology and non-oncology products.


Shivalik Rasayan’s API facility gets 7 observations from USFDA
Drug Approval | April 10, 2024

Shivalik Rasayan’s API facility gets 7 observations from USFDA

These observations are procedural in nature and will be responded within the stipulated time