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Results For "regulatory"

1216 News Found

Neuland appoints Parag Deshmukh as SVP – Head of Manufacturing
People | March 24, 2025

Neuland appoints Parag Deshmukh as SVP – Head of Manufacturing

Prior to joining Neuland, Deshmukh held several key positions at Cipla


SMS Pharmaceuticals completes USFDA inspection at Hyderabad facility
Drug Approval | March 22, 2025

SMS Pharmaceuticals completes USFDA inspection at Hyderabad facility

The inspection, conducted from March 17 to March 21, 2025, concluded with one observation in Form 483


BrePco Biopharma and Piramal Critical Care announce MHRA approval for Neoatricon in UK
Drug Approval | March 21, 2025

BrePco Biopharma and Piramal Critical Care announce MHRA approval for Neoatricon in UK

PCC has secured the commercialization rights for the EU, UK, and Norway and will be responsible for distributing Neoatricon in these regions


USFDA grants Priority Review for new indication of finerenone for patients with common heart failure
Drug Approval | March 20, 2025

USFDA grants Priority Review for new indication of finerenone for patients with common heart failure

Finerenone is the first drug targeting the mineralocorticoid receptor (MR) pathway to demonstrate cardiovascular benefits in a Phase III study in patients with heart failure


Healthcare Triangle appoints Sujatha Ramesh as COO
People | March 20, 2025

Healthcare Triangle appoints Sujatha Ramesh as COO

Previously, Sujatha has held leadership positions at prominent organizations, including Publicis Sapient, Infinite Computer Solutions, and Capgemini


RedHill Biopharma to submit FDA-approved Talicia for UK marketing authorisation
Drug Approval | March 19, 2025

RedHill Biopharma to submit FDA-approved Talicia for UK marketing authorisation

Talicia is also approved and launched in the UAE and additional countries may accept UK MHRA approvals as a reference for their own marketing approval processes


Poly Medicure receives MDR certification for 54 products
News | March 12, 2025

Poly Medicure receives MDR certification for 54 products

The MDR certification reafirms that these products meet the highest safety, quality, and regulatory standards


Astellas and YASKAWA to establish JV focused on cell therapy manufacturing
News | March 10, 2025

Astellas and YASKAWA to establish JV focused on cell therapy manufacturing

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


Biocon Biologics announces positive results from Phase 3 study of Yesintek biosimilar to Ustekinumab for chronic plaque psoriasis
Diagnostic Center | March 08, 2025

Biocon Biologics announces positive results from Phase 3 study of Yesintek biosimilar to Ustekinumab for chronic plaque psoriasis

The study demonstrated equivalent efficacy, safety, immunogenicity, and pharmacokinetics between YESINTEK and the reference product Stelara


Amaran Biotech signs MOU with Nippon Fine Chemical to expand CDMO business
News | March 08, 2025

Amaran Biotech signs MOU with Nippon Fine Chemical to expand CDMO business

Amaran Biotech boasts Taiwan’s first fully automated robotic aseptic filling line, offering high-quality and low-waste filling solutions for high-value pharmaceuticals