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Legal & RegulatoryEvent: September 8, 2026

Cromos Pharma approved Replimune melanoma therapy in August 2026 after it was rejected twice.

Published

Signal category

Legal & Regulatory

Quote

Then, in August 2026, it approved it.

Cromos Pharma team

Company

Cromos Pharma

US-based international CRO helping clients develop drugs and treatments that save and improve the lives of patients

Industry
Research Services
Location
Dallas, US
Company size
168 employees

Cromos Pharma is a US-based, international contract research organization delivering fully integrated clinical research solutions, in all trial phases, across a wide range of therapeutic indications. Our expert team, comprised of 95% MDs, has extensive expertise in study design, medical writing, regulatory affairs, site management, patient recruitment and data management. Cromos Pharma has experience in delivering success in a wide range of trial types, from biosimilars and generics, to successfully managing trials of novel therapeutics in a wide range of clinical indications. Our team provides full-service solutions to international pharma and biotech companies in high-recruiting regions, assuring exceptional data quality. Cromos Pharma combines global expertise with in-depth experience and knowledge in the US, Central and Eastern Europe, Central Asia, Republic of Georgia, and Türkiye resulting in rapid patient recruitment. Our team has met or reduced enrollment timelines in 95% of conducted trials. We provide accelerated study start-up timelines in our regions of operation. Regulatory inspections by FDA and EMA and site audits attest to the highest quality of our clinical data. Established in 2004, Cromos Pharma has strong regional experience that is supported by a global network of offices. Its international HQ is in Dallas, Texas, USA and its European HQ is in Dublin, Ireland.

Founded 2004

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