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2770 News Found

Granules India’s Gagillapur facility completes USFDA inspection with six observations
Drug Approval | September 09, 2024

Granules India’s Gagillapur facility completes USFDA inspection with six observations

The recent inspection covered both cGMP and PAI processes


Beiersdorf and Macro Biologics announce partnership to develop antimicrobial peptides
News | September 06, 2024

Beiersdorf and Macro Biologics announce partnership to develop antimicrobial peptides

Multi-year collaboration focuses on development of biodegradable antimicrobial peptides with broad application possibilities in the areas of skin care and healthcare


Enzene appoints new site lead of biologics manufacturing
People | September 04, 2024

Enzene appoints new site lead of biologics manufacturing

He will lead the final stages of work to commission the 54,000-square-foot facility and then lead ongoing operations at the site


Finerenone showed statistically significant improvement in cardiovascular outcomes in adults with common form of heart failure
Clinical Trials | September 02, 2024

Finerenone showed statistically significant improvement in cardiovascular outcomes in adults with common form of heart failure

Finerenone is the first mineralocorticoid receptor (MR) antagonist to demonstrate definitive cardiovascular benefits in a Phase III study in patients with heart failure (HF) with a left ventricular ejection fraction (LVEF) of ?40%


Biocon Biologics secures market entry for Bmab 1200 in Europe, UK, Canada, and Japan
News | August 30, 2024

Biocon Biologics secures market entry for Bmab 1200 in Europe, UK, Canada, and Japan

Biocon Biologics earlier announced a settlement agreement in the United States for a Bmab 1200 launch no later than February 22, 2025


Natco Pharma announces submission of TABRECTA to USFDA
Drug Approval | August 30, 2024

Natco Pharma announces submission of TABRECTA to USFDA

TABRECTA is the brand of Novartis. Natco believes it is the first company to have filed a substantially-complete ANDA


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


Lupin receives USFDA approval for Brimonidine Tartrate Ophthalmic Solution, 0.1%
Drug Approval | August 28, 2024

Lupin receives USFDA approval for Brimonidine Tartrate Ophthalmic Solution, 0.1%

Brimonidine Tartrate Ophthalmic Solution, 0.1% is an alpha adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure


Aptar Closures introduces new lightweight 2? Disc Top Lite Closure for beauty and personal care
News | August 28, 2024

Aptar Closures introduces new lightweight 2? Disc Top Lite Closure for beauty and personal care

The low-profile, 2” Disc Top Lite closure offers lighter weight combined with premium customization options