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ICER has weighed in on two of the 10 drugs selected for negotiations: Eliquis and Xarelto, which are among Medicare Part D’s highest spending drugs.


CMS Moves Forward with Medicare Drug Price Negotiations


In a confirmatory trial, Exkivity did not meet the primary endpoint in treating patients with non-small cell lung cancer with EGFR exon 20 mutations. It will remain available while Takeda works with the FDA on withdrawal timing.


Takeda to Withdraw Oncology Drug Exkivity from U.S. Market

Director of Nonprofit Strategy, Patient Advocacy, IQVIA

Patient organizations should focus on how they can be the most effective by leveraging their strengths to uncover new research opportunities.

Maximizing Impact Through Strategic Research Investments That Address Unmet Needs


The FDA has approved several new therapies this week, including a new two-component Pompe therapy, an extended-release drug for major depression without sexual side effects, and an eye drop for drug-induced dilation. Additionally, the agency has set review dates for several products, including odronextamab for blood cancers, sotatercept for pulmonary arterial hypertension, and Dupixent in young children with eosinophilic esophagitis.


FDA Updates for the Week of Sept. 25, 2023

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Sandesh Prabhu, MD, MBA

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