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Accelerated review status enables CHMP to grant an opinion two months earlier than the standard 210-day period. In XBiotech’s case, a decision may happen as early as third

Nimbus will get $400m up front and up to $800m if certain development milestones are reached. The Nimbus Apollo program includes lead candidate NDI-010976 and other preclinical ACC

The CHMP also added an informative statement to the broad indication that relative to Opdivo monotherapy, an increase in progression-free survival (PFS) for the combination of Opdivo with

The TERRA study met its primary endpoint of demonstrating improvement in overall survival (OS) in patients with refractory mCRC whose disease had progressed after approved standard therapies. In

The first study in this program completed enrollment at the end of January and the second study has now completed enrollment. The results from the first study are

DSG will deliver a fully supported eCaseLink EDC system, including IWRS Web-based randomization-clinical supply, a central lab and third-party CRO data integration, and data management services. The move

The drug, dupilumab, improved rash, itching and other symptoms of AD, which is a severe form of eczema. The SOLO1 and SOLO2 studies met their primary endpoints in

Stremvelis is a stem cell gene therapy created from the patient’s own cells. It was designated as an orphan medicinal product in August 2005. It was originally developed

Based upon the documented relationship of P450 and certain potential drug-drug interactions, this positive data is central to the planned Phase 2 clinical trial where Kevetrin will be