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Results For "regulatory"

1533 News Found

Roche provides update on astegolimab in chronic obstructive pulmonary disease
Clinical Trials | July 21, 2025

Roche provides update on astegolimab in chronic obstructive pulmonary disease

The phase III ARNASA study did not meet the primary endpoint of a statistically significant reduction in the AER at 52 weeks


Sun Pharma’s phase 3 Cclinical studies for Tildrakizumab 100 mg meet primary endpoint
Clinical Trials | July 21, 2025

Sun Pharma’s phase 3 Cclinical studies for Tildrakizumab 100 mg meet primary endpoint

The INSPIRE-1 and INSPIRE-2 trials are Phase 3 studies assessing the efficacy and safety of tildrakizumab 100 mg (ILUMYA) in adults with active psoriatic arthritis (PsA)


ImCheck’s ICT01 receives FDA ODD for treatment of acute myeloid leukemia
Clinical Trials | July 21, 2025

ImCheck’s ICT01 receives FDA ODD for treatment of acute myeloid leukemia

Clinical data showing unprecedented remission rates in newly diagnosed AML patients support advancing ICT01 into pivotal trials


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


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