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Merck KGAA

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Latest From Merck KGAA

US FDA Fine-Tunes Tecentriq, Keytruda First-Line Bladder Cancer Accelerated Approval Indications

FDA’s decision to restrict use based on the level of PD-L1 expression shows how confirmatory trials for accelerated approval can help to inform and adapt labeling. 

Approvals Post Market Regulation & Studies

Pipeline Watch Phase III Progress With Trintellix, Ocrevus And Olumiant

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Pipeline Watch Approvals

Roche’s External Control Arms Show What Real-World Evidence Can Look Like In Practice

With Flatiron, Roche is at the forefront of the emerging field of RWE. Roche Pharma President O’Day described how the company is using such data in the real world of regulation and reimbursement.

Clinical Trials Digital Health

Pipeline Watch: Phase III Progress With Nimotuzumab, Solriamfetol, And Upadacitinib

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

 

Approvals Research & Development
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