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Results For "regulator"

1844 News Found

Concord Biotech announces successful completion EU GMP inspection at its API facility
News | July 18, 2025

Concord Biotech announces successful completion EU GMP inspection at its API facility

This achievement underscores our unwavering commitment to upholding the highest standards of quality, safety, and regulatory compliance


Evonik opens new medical device center in Shanghai
News | July 12, 2025

Evonik opens new medical device center in Shanghai

The company’s largest center for medical device applications, serving the entire Asian market


Indegene launches NEXT Medical Writing Automation
News | July 12, 2025

Indegene launches NEXT Medical Writing Automation

To streamline complex medical writing workflows with GenAI


Ichnos Glenmark Innovation announces global commercialization strategy for ISB 2001
News | July 11, 2025

Ichnos Glenmark Innovation announces global commercialization strategy for ISB 2001

IGI partners with AbbVie and grants exclusive rights to globally develop, manufacture, and commercialize ISB 2001 across North America, Europe, Japan, and Greater China


Shilpa Medicare Unit VI facility at Dabaspet receives GMP certification from SFDA
Drug Approval | July 11, 2025

Shilpa Medicare Unit VI facility at Dabaspet receives GMP certification from SFDA

This was a full GMP inspection of the entire facility with specific focus on Ondansetron Oral Film drug product


Bayer receives first approval for Lynkuet in UK as treatment for vasomotor symptoms associated with menopause
Drug Approval | July 11, 2025

Bayer receives first approval for Lynkuet in UK as treatment for vasomotor symptoms associated with menopause

The UK authorization is based on positive results from the Phase III OASIS-1, -2, and -3 trials


Lupin and Zentiva sign license and supply agreement for commercializing Certolizumab
News | July 09, 2025

Lupin and Zentiva sign license and supply agreement for commercializing Certolizumab

Lupin and Zentiva sign license and supply agreement for commercializing Certolizumab


Novo Nordisk submits application to EMA for higher dose of Wegovy for obesity treatment
Clinical Trials | July 09, 2025

Novo Nordisk submits application to EMA for higher dose of Wegovy for obesity treatment

The submission is based on data from the STEP UP and STEP UP T2D clinical trials


OneSource Specialty Pharma appoints Jeffrey Wong as CBO
People | July 08, 2025

OneSource Specialty Pharma appoints Jeffrey Wong as CBO

He has held senior leadership positions at Syngene International, Fujifilm Diosynth Biotechnologies, Thermo Fisher Scientific, Sartorius Stedim Biotech, and other leading organizations