USFDA accepts sBLA of TIVDAK for priority review for patients with metastatic cervical cancer
Submission based on positive results from global phase 3 study demonstrating overall survival benefit of TIVDAK over chemotherapy
Submission based on positive results from global phase 3 study demonstrating overall survival benefit of TIVDAK over chemotherapy
If approved, patritumab deruxtecan would be a first-in-class HER3 directed DXd antibody drug conjugate for these patients
Sarclisa added to bortezomib, lenalidomide and dexamethasone (VRd) significantly reduced the risk of disease progression or death compared with VRd alone
Accelerating FDA submission and confirming potential to become first approved biologic for this serious disease
Merck to pay Daiichi Sankyo a $4 billion upfront payment in addition to $1.5 billion in continuation payments over the next 24 months
Kivo’s expanded platform brings compliant collaboration and intelligent process automation to emerging Regulatory, Clinical and Quality teams
In 2030 over 50% of FDA approvals will involve AI discovered and developed drugs
LEO Pharma is developing delgocitinib cream for the treatment of moderate to severe chronic hand eczema, a hard-to-treat disease where there is a high unmet medical need for treatment
Jemperli is the only immuno-oncology treatment approved in the frontline setting for this patient population in combination with chemotherapy
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