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Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is used in combination with

Turing head of research and development Eliseo Salinas said: "I’m happy to report that TUR-004 was well tolerated and assessments continue as planned. "This is certainly a small

The DMC recommendation is based upon a predefined interim analysis indicating a statistically significant benefit in efficacy for progression-free survival (PFS) and overall survival (OS) in patients receiving

The FDA previously granted Opdivo Breakthrough Therapy Designation for this indication, underscoring the critical need for new treatment options for patients with advanced RCC who have received prior

The company received notification from French pharmaceutical regulatory agency l’Agence National de Sécurité du Médicament et des produits de santé (ANSM) to suspend manufacturing within the site. Catalent

Sparsentan, also known as RE-021, is an investigational therapeutic agent which acts as a potent angiotensin receptor blocker, and a selective endothelin receptor antagonist, with in vitro selectivity

Under the collaboration, Emerson’s DeltaV distributed control system will be integrated with GE’s technologies to manufacture monoclonal antibodies, vaccines and other biologics. The initial DeltaV-driven GE Healthcare installation

Darzalex is a monoclonal antibody that is designed to help the body’s immune system fight cancer cells. In clinical studies involving over 140 people, Darzalex reduced the cancer’s

The 455-patient randomized, double-masked, vehicle-controlled, dose-ranging study (ClinicalTrials.gov Identifier: NCT02254265) was conducted at 28 investigational sites in the U.S. In the study, both concentrations (0.05% and 0.09%) of